Trial Outcomes & Findings for Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis (NCT NCT02244606)
NCT ID: NCT02244606
Last Updated: 2024-06-25
Results Overview
All Related TEAEs by SOC and PT, by Treatment, Safety
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
up to 10 weeks
Results posted on
2024-06-25
Participant Flow
A total of 27 participants were enrolled, two of whom failed to meet all inclusion and exclusion criteria and were considered screen failures. Among the 25 enrolled participants who met all inclusion and exclusion criteria, three were not randomized. Thus, 22 patients were randomized to receive SCY-078 500 mg or SCY-078 750 mg or standard-of-care.
Participant milestones
| Measure |
Ibrexafungerp 500-mg
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
1
|
|
Overall Study
Did Not Receive Study Drug
|
1
|
0
|
0
|
0
|
|
Overall Study
Did Not Complete Randomized Study Drug
|
1
|
1
|
2
|
0
|
|
Overall Study
COMPLETED
|
4
|
2
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
3
|
1
|
Reasons for withdrawal
| Measure |
Ibrexafungerp 500-mg
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Overall Study
Did Not Complete Study for Reason Other:
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Baseline characteristics by cohort
| Measure |
Ibrexafungerp 500-mg
n=7 Participants
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
n=7 Participants
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
n=7 Participants
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
n=1 Participants
IV micafungin 100 mg daily
|
Total
n=22 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 7.81 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 15.46 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 15.66 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION NA • n=4 Participants
|
52.1 years
STANDARD_DEVIATION 13.17 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
19 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
17 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
1 participants
n=4 Participants
|
22 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 10 weeksPopulation: ITT
All Related TEAEs by SOC and PT, by Treatment, Safety
Outcome measures
| Measure |
Ibrexafungerp 500-mg
n=6 Participants
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
n=7 Participants
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
n=7 Participants
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
n=1 Participants
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
Patients with no Drug- Related TEAE
|
5 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
|
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
Patients with at least One Drug-Related TEAE
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hours post-dosePopulation: Pharmacokinetic Population
Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK
Outcome measures
| Measure |
Ibrexafungerp 500-mg
n=5 Participants
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
n=5 Participants
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Dose of SCY-078 That Achieves the Target Exposure (AUC)
|
3 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: end of all antifungal therapy (administered for a maximum of 28 days)Population: ITT
Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture)
Outcome measures
| Measure |
Ibrexafungerp 500-mg
n=7 Participants
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
n=7 Participants
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
n=7 Participants
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
n=1 Participants
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Global Response
Favorable
|
5 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
|
Global Response
Unfavorable
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: end of all antifungal therapy (administered for a maximum of 28 days)Population: ITT
Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy
Outcome measures
| Measure |
Ibrexafungerp 500-mg
n=7 Participants
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
n=7 Participants
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
n=7 Participants
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
n=1 Participants
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Clinical Response
Favorable
|
5 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
|
Clinical Response
Unfavorable
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Clinical Response
Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: end of all antifungal therapy (administered for a maximum of 28 days)Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection
Outcome measures
| Measure |
Ibrexafungerp 500-mg
n=7 Participants
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
n=7 Participants
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
n=7 Participants
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
n=1 Participants
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Microbiological Response
Favorable
|
6 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Microbiological Response
Unfavorable
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Microbiological Response
Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeksPopulation: Intent-To-Treat (ITT): All randomized participants Overall number of participants includes all randomized participants, number analyzed includes participants analyzed at a particular time point.
If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered
Outcome measures
| Measure |
Ibrexafungerp 500-mg
n=7 Participants
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
n=7 Participants
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
n=7 Participants
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
n=1 Participants
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Relapse
Week 2 Post-Treatment · Relapsed
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Relapse
Week 6 Post-Treatment · Not Evaluable or Missing
|
3 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Relapse
Week 2 Post-Treatment · Did Not Relapse
|
4 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Relapse
Week 2 Post-Treatment · Not Evaluable or Missing
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Relapse
Week 6 Post-Treatment · Relapsed
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Relapse
Week 6 Post-Treatment · Did Not Relapse
|
4 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
Adverse Events
Ibrexafungerp 500-mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Ibrexafungerp 750-mg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Standard of Care (Fluconazole)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Standard of Care (Micafungin)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibrexafungerp 500-mg
n=6 participants at risk
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
n=7 participants at risk
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
n=7 participants at risk
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
n=1 participants at risk
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Infections and infestations
Abscess neck
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Bacteremia
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Fungemia
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/6
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/1
|
|
Infections and infestations
Septic shock
|
0.00%
0/6
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukemia recurrent
|
0.00%
0/6
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer extensive stage
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Syncope
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Renal tubular necrosis
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/1
|
Other adverse events
| Measure |
Ibrexafungerp 500-mg
n=6 participants at risk
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
|
Ibrexafungerp 750-mg
n=7 participants at risk
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
|
Standard of Care (Fluconazole)
n=7 participants at risk
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day
|
Standard of Care (Micafungin)
n=1 participants at risk
IV micafungin 100 mg daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6
|
14.3%
1/7
|
28.6%
2/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
28.6%
2/7
|
14.3%
1/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/1
|
|
Nervous system disorders
Headache
|
16.7%
1/6
|
28.6%
2/7
|
28.6%
2/7
|
0.00%
0/1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6
|
28.6%
2/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6
|
28.6%
2/7
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Pyrexia
|
0.00%
0/6
|
0.00%
0/7
|
28.6%
2/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place