Trial Outcomes & Findings for ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection (NCT NCT03183141)
NCT ID: NCT03183141
Last Updated: 2023-04-10
Results Overview
Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
263 participants
Primary outcome timeframe
Up to Week 8
Results posted on
2023-04-10
Participant Flow
Overall, there were 64 sites in the United States and 8 sites in Canada that enrolled participants between 2017 to 2021.
Participant milestones
| Measure |
Cohort 1
Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study.
|
Cohort 2
Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
234
|
|
Overall Study
Completed 8-week Follow-up
|
29
|
228
|
|
Overall Study
COMPLETED
|
27
|
222
|
|
Overall Study
NOT COMPLETED
|
2
|
12
|
Reasons for withdrawal
| Measure |
Cohort 1
Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study.
|
Cohort 2
Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Death
|
0
|
8
|
Baseline Characteristics
ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
Baseline characteristics by cohort
| Measure |
Cohort 1
n=29 Participants
Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study.
|
Cohort 2
n=234 Participants
Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.7 years
STANDARD_DEVIATION 12.46 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 15.79 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 15.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Antibiotic regimen for qualifying episode
Vancomycin
|
22 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Antibiotic regimen for qualifying episode
Fidaxomicin
|
7 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 8Population: The analysis population consisted of all enrolled participants.
Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.
Outcome measures
| Measure |
Cohort 1
n=29 Participants
Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study.
|
|---|---|
|
Cohort 1: Recurrence of CDI and Sustained Clinical Response
Number of participants with CDI recurrence
|
4 Participants
|
|
Cohort 1: Recurrence of CDI and Sustained Clinical Response
Number of participants with sustained response
|
25 Participants
|
PRIMARY outcome
Timeframe: Up to Weeks 8 and 12Population: The analysis population consisted of all enrolled participants.
Cohort 2: Recurrence of CDI up to 8 and 12 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 and 12 Weeks after treatment.
Outcome measures
| Measure |
Cohort 1
n=234 Participants
Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study.
|
|---|---|
|
Cohort 2: Recurrence of CDI and Sustained Clinical Response
Week 8 · Number of participants with CDI recurrence
|
19 Participants
|
|
Cohort 2: Recurrence of CDI and Sustained Clinical Response
Week 8 · Number of participants with sustained clinical response
|
215 Participants
|
|
Cohort 2: Recurrence of CDI and Sustained Clinical Response
Week 12 · Number of participants with CDI recurrence
|
23 Participants
|
|
Cohort 2: Recurrence of CDI and Sustained Clinical Response
Week 12 · Number of participants with sustained clinical response
|
211 Participants
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 2
Serious events: 32 serious events
Other events: 68 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Cohort 1
n=29 participants at risk
Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study.
|
Cohort 2
n=234 participants at risk
Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
1.7%
4/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
1.3%
3/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.85%
2/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
1.7%
4/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.85%
2/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Urosepsis
|
3.4%
1/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Abscess
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Cytomegalovirus viremia
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Escherichia bacteremia
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Necrotizing fasciitis
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.85%
2/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Duodenal ulcer hemorrhage
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Gastric ulcer hemorrhage
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.85%
2/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.85%
2/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.85%
2/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.85%
2/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Investigations
Amylase increased
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Investigations
Lipase increased
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Investigations
Platelet count decreased
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Musculoskeletal and connective tissue disorders
Chest wall hematoma
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Musculoskeletal and connective tissue disorders
Chronic recurrent multifocal osteomyelitis
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
General disorders
Death due to natural causes
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Product Issues
Device occlusion
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Skin and subcutaneous tissue disorders
Vasculitic ulcer
|
0.00%
0/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
0.43%
1/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
Other adverse events
| Measure |
Cohort 1
n=29 participants at risk
Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study.
|
Cohort 2
n=234 participants at risk
Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
34.5%
10/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
20.5%
48/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Flatulence
|
13.8%
4/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
6.8%
16/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
3/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
7.3%
17/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
3/29 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
6.4%
15/234 • 24 weeks follow-up starting Day 1 post-dosing with SER-109
All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
|
Additional Information
Lisa von Moltke, MD, Chief Medical Officer
Seres Therapeutics
Phone: 617-945-9626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place