Trial Outcomes & Findings for Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection (NCT NCT03788434)

Last Updated: 2023-07-03

Results Overview

Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	VE303 High Dose Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.
Overall Study STARTED	30	27	22
Overall Study COMPLETED	29	27	22
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VE303 High Dose n=30 Participants Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose n=27 Participants Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo n=22 Participants Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	40 Participants n=4 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	39 Participants n=4 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 14.99 • n=5 Participants	62.9 years STANDARD_DEVIATION 17.85 • n=7 Participants	60.8 years STANDARD_DEVIATION 15.98 • n=5 Participants	62.1 years STANDARD_DEVIATION 16.12 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	27 Participants n=7 Participants	22 Participants n=5 Participants	77 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	25 Participants n=7 Participants	22 Participants n=5 Participants	76 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	18 participants n=5 Participants	17 participants n=7 Participants	14 participants n=5 Participants	49 participants n=4 Participants
Region of Enrollment Canada	12 participants n=5 Participants	10 participants n=7 Participants	8 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).

Outcome measures

Outcome measures
Measure	VE303 High Dose n=29 Participants Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose n=27 Participants Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo n=22 Participants Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.
CDI Recurrence Week 8 C. difficile recurrences (toxin-positive)	4 Participants	9 Participants	5 Participants
CDI Recurrence Week 8 C. difficile recurrences (laboratory-confirmed)	4 Participants	10 Participants	8 Participants
CDI Recurrence Week 8 C. difficile recurrences (laboratory-confirmed or clinically diagnosed and treated)	4 Participants	10 Participants	10 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Enrolled subjects who provided stool samples for analysis at week 24.

Characterize the number of VE303 strains detected in the fecal microbiome at week 24.

Outcome measures

Outcome measures
Measure	VE303 High Dose n=20 Participants Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose n=21 Participants Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo n=14 Participants Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.
VE303 Strains Detected	3.25 Number of VE303 strains detected Standard Deviation 2.807	1.62 Number of VE303 strains detected Standard Deviation 1.962	0.36 Number of VE303 strains detected Standard Deviation 0.633

SECONDARY outcome

Timeframe: 24 weeks

Population: Enrolled subjects who provided stool samples for analysis at week 24.

Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample.

Outcome measures

Outcome measures
Measure	VE303 High Dose n=20 Participants Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose n=21 Participants Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo n=14 Participants Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.
VE303 Relative Abundance	0.01186 Proportion of VE303 strains Standard Deviation 0.013897	0.00775 Proportion of VE303 strains Standard Deviation 0.016007	0.00097 Proportion of VE303 strains Standard Deviation 0.002297

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks

Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 4 (i.e., 4 weeks after the first dose of study treatment).

Outcome measures

Outcome measures
Measure	VE303 High Dose n=29 Participants Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose n=27 Participants Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo n=22 Participants Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.
CDI Recurrence Week 4 C. difficile recurrences (laboratory-confirmed)	4 Participants	10 Participants	5 Participants
CDI Recurrence Week 4 C. difficile recurrences (laboratory-confirmed, or clinically diagnosed and treated)	4 Participants	10 Participants	6 Participants
CDI Recurrence Week 4 C. difficile recurrences (toxin-positive)	4 Participants	9 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 12 (i.e., 12 weeks after the first dose of study treatment).

Outcome measures

Outcome measures
Measure	VE303 High Dose n=29 Participants Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose n=27 Participants Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo n=22 Participants Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.
CDI Recurrence Week 12 C. difficile recurrences (toxin-positive)	4 Participants	9 Participants	5 Participants
CDI Recurrence Week 12 C. difficile recurrences (laboratory-confirmed)	4 Participants	10 Participants	8 Participants
CDI Recurrence Week 12 C. difficile recurrences (laboratory-confirmed, or clinically diagnosed and treated)	4 Participants	10 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks

Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 24 (i.e., 24 weeks after the first dose of study treatment).

Outcome measures

Outcome measures
Measure	VE303 High Dose n=29 Participants Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose n=27 Participants Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo n=22 Participants Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.
CDI Recurrence Week 24 C. difficile recurrences (toxin-positive)	4 Participants	9 Participants	5 Participants
CDI Recurrence Week 24 C. difficile recurrences (laboratory-confirmed)	5 Participants	11 Participants	8 Participants
CDI Recurrence Week 24 C. difficile recurrences (laboratory-confirmed or clinically diagnosed and treated)	5 Participants	11 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VE303 High Dose n=29 participants at risk Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose n=27 participants at risk Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo n=22 participants at risk Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/29 • 24 weeks	0.00% 0/27 • 24 weeks	4.5% 1/22 • Number of events 1 • 24 weeks
Gastrointestinal disorders Nausea	0.00% 0/29 • 24 weeks	0.00% 0/27 • 24 weeks	4.5% 1/22 • Number of events 1 • 24 weeks
Gastrointestinal disorders Vomiting	0.00% 0/29 • 24 weeks	0.00% 0/27 • 24 weeks	4.5% 1/22 • Number of events 1 • 24 weeks
Infections and infestations CDI	0.00% 0/29 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	0.00% 0/22 • 24 weeks
Infections and infestations Escherichia Bacteraemia	0.00% 0/29 • 24 weeks	0.00% 0/27 • 24 weeks	4.5% 1/22 • Number of events 1 • 24 weeks
Infections and infestations Pyelonephritis	0.00% 0/29 • 24 weeks	0.00% 0/27 • 24 weeks	4.5% 1/22 • Number of events 1 • 24 weeks
Injury, poisoning and procedural complications Transfusion Reaction	3.4% 1/29 • Number of events 1 • 24 weeks	0.00% 0/27 • 24 weeks	0.00% 0/22 • 24 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/29 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	0.00% 0/22 • 24 weeks
Nervous system disorders Cerebrovascular Accident	0.00% 0/29 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	0.00% 0/22 • 24 weeks
Nervous system disorders Dizziness	0.00% 0/29 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	0.00% 0/22 • 24 weeks
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/29 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	0.00% 0/22 • 24 weeks

Other adverse events

Other adverse events
Measure	VE303 High Dose n=29 participants at risk Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	VE303 Low Dose n=27 participants at risk Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.	Placebo n=22 participants at risk Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.
Gastrointestinal disorders Diarrhea	72.4% 21/29 • Number of events 243 • 24 weeks	85.2% 23/27 • Number of events 213 • 24 weeks	86.4% 19/22 • Number of events 114 • 24 weeks
Gastrointestinal disorders Nausea	20.7% 6/29 • Number of events 7 • 24 weeks	22.2% 6/27 • Number of events 6 • 24 weeks	9.1% 2/22 • Number of events 2 • 24 weeks
Gastrointestinal disorders Abdominal Pain	17.2% 5/29 • Number of events 7 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	9.1% 2/22 • Number of events 2 • 24 weeks
Gastrointestinal disorders Vomiting	3.4% 1/29 • Number of events 2 • 24 weeks	14.8% 4/27 • Number of events 4 • 24 weeks	13.6% 3/22 • Number of events 3 • 24 weeks
Gastrointestinal disorders Abdominal Distension	6.9% 2/29 • Number of events 3 • 24 weeks	3.7% 1/27 • Number of events 2 • 24 weeks	9.1% 2/22 • Number of events 2 • 24 weeks
Gastrointestinal disorders Flatulence	6.9% 2/29 • Number of events 2 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	9.1% 2/22 • Number of events 2 • 24 weeks
Gastrointestinal disorders Constipation	10.3% 3/29 • Number of events 3 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	0.00% 0/22 • 24 weeks
Gastrointestinal disorders Dyspepsia	3.4% 1/29 • Number of events 1 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	4.5% 1/22 • Number of events 1 • 24 weeks
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/29 • 24 weeks	0.00% 0/27 • 24 weeks	13.6% 3/22 • Number of events 4 • 24 weeks
Gastrointestinal disorders Irritable Bowel Syndrome	6.9% 2/29 • Number of events 2 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	0.00% 0/22 • 24 weeks
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/29 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	0.00% 0/22 • 24 weeks
Gastrointestinal disorders Abdominal Pain Upper	6.9% 2/29 • Number of events 2 • 24 weeks	0.00% 0/27 • 24 weeks	0.00% 0/22 • 24 weeks
Gastrointestinal disorders Eructation	0.00% 0/29 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	0.00% 0/22 • 24 weeks
General disorders Chills	6.9% 2/29 • Number of events 2 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	0.00% 0/22 • 24 weeks
General disorders Pyrexia	0.00% 0/29 • 24 weeks	14.8% 4/27 • Number of events 4 • 24 weeks	0.00% 0/22 • 24 weeks
General disorders Fatigue	6.9% 2/29 • Number of events 2 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	0.00% 0/22 • 24 weeks
General disorders Oedema Peripheral	0.00% 0/29 • 24 weeks	3.7% 1/27 • Number of events 1 • 24 weeks	9.1% 2/22 • Number of events 2 • 24 weeks
General disorders Malaise	0.00% 0/29 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	0.00% 0/22 • 24 weeks
Infections and infestations Urinary Tract Infection	3.4% 1/29 • Number of events 1 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	18.2% 4/22 • Number of events 4 • 24 weeks
Injury, poisoning and procedural complications Fall	0.00% 0/29 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	0.00% 0/22 • 24 weeks
Investigations Blood Potassium Increased	6.9% 2/29 • Number of events 2 • 24 weeks	0.00% 0/27 • 24 weeks	0.00% 0/22 • 24 weeks
Metabolism and nutrition disorders Dehydration	3.4% 1/29 • Number of events 1 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	0.00% 0/22 • 24 weeks
Nervous system disorders Headache	6.9% 2/29 • Number of events 2 • 24 weeks	11.1% 3/27 • Number of events 3 • 24 weeks	0.00% 0/22 • 24 weeks
Nervous system disorders Dizziness	0.00% 0/29 • 24 weeks	11.1% 3/27 • Number of events 3 • 24 weeks	4.5% 1/22 • Number of events 1 • 24 weeks
Nervous system disorders Dysgeusia	6.9% 2/29 • Number of events 3 • 24 weeks	0.00% 0/27 • 24 weeks	9.1% 2/22 • Number of events 2 • 24 weeks
Respiratory, thoracic and mediastinal disorders Cough	3.4% 1/29 • Number of events 1 • 24 weeks	7.4% 2/27 • Number of events 2 • 24 weeks	0.00% 0/22 • 24 weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/29 • 24 weeks	0.00% 0/27 • 24 weeks	9.1% 2/22 • Number of events 2 • 24 weeks

Additional Information

Jeffrey Silber

Vedanta Biosciences

Phone: (857) 706-1427

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place