Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
Study Details
Study Description
Brief Summary
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (for a subset of subjects) of oral SCY-078 in male and female subjects ≥18 years of age with a documented Candida auris infection. Patients will be treated with SCY-078 for up to 90 days.
Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to be considered for enrollment. Subjects are also eligible if they are receiving intravenous (IV) antifungal therapy for their C. auris infection and, in the judgment of the investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion. Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment.
Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts (survival visits)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SCY-078 SCY-078 |
Drug: SCY-078
Oral SCY-078
|
Outcome Measures
Primary Outcome Measures
- Efficacy as measured by the percentage of subjects with global success at end of treatment [Up to 90 days of study treatment]
Efficacy as measured by the percentage of subjects with global success (complete or partial global response) at EoT as determined by the Data Monitoring Committee
Secondary Outcome Measures
- Number of participants with treatment-related Adverse Events (Safety) [Through study completion, an average of 132 days]
Number of participants with Adverse Events that are related to treatment
- Number of participants with Discontinuations due to Adverse Events (Safety) [Through study completion, an average of 132 days]
Number of participants with Discontinuations due to Adverse Events
- Recurrence of Baseline Fungal Infection (Efficacy) [up to 42 days after end of study treatment]
Assessment of Recurrence of Baseline Fungal Infection The proportion of subjects with a recurrence of the baseline fungal infection
- Survival (Safety and Efficacy) [Day 42 and Day 84]
Proportion of surviving subjects
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subject must fulfill the following KEY criteria to be eligible for study admission:
-
Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed.
-
Subject has a documented candidiasis, including candidemia, caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. A documented candidiasis, including candidemia, caused by Candida auris is defined as the recovery of Candida auris by culture of a sample obtained within the last 7 days.
-
Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.
Exclusion Criteria:
- KEY exclusion criteria:
-
Subject has a fungal disease with central nervous system involvement.
-
Subject has a fungal disease of the bone and/or joint that is expected to require
90 days of study drug treatment.
-
Subject has an inappropriately controlled fungal infection source (e.g., persistent catheters, devices, identified abscess) that is likely the source of the fungal infection.
-
Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support.
-
Subject has abnormal liver test parameters: AST or ALT >10 x ULN, and/or total bilirubin >5 x ULN. Note: Subjects with unconjugated hyperbilirubinemia with diagnosis of Gilbert's disease are not excluded.
-
Subject has an Apache score >16.
-
Subject has serum creatinine >3 times from Baseline (Screening/Treatment Day 1) value.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Scynexis, Inc. | Jersey City | New Jersey | United States | 07302 |
| 2 | St John's Medical College and Hospital | Bangalore | Karnataka | India | 560034 |
| 3 | Amrita Institute of Medical Sciences (AIMS) | Kanayannur | Kochi | India | 682041 |
| 4 | Institute of Critical Care Medicine Max Super Specialty Hospital | Saket | New Delhi | India | 110017 |
| 5 | King George Medical University | Lucknow | Uttar Pradesh | India | 226003 |
| 6 | Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care | Chandigarh | India | 160012 | |
| 7 | Aga Khan University Hospital | Karachi | Sindh | Pakistan | 74800 |
| 8 | Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157 | Centurion | Gauteng | South Africa | 0157 |
| 9 | Emmed Research, Jakarta Hospital | Pretoria | Gauteng | South Africa | 0002 |
| 10 | Into Research, Life Groenkloof Hospital | Pretoria | Gauteng | South Africa | 0181 |
| 11 | Johese Clinical Research, Midstream | Pretoria | Gauteng | South Africa | 1692 |
Sponsors and Collaborators
- Scynexis, Inc.
Investigators
- Study Director: David Angulo, MD, Scynexis, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- Berkow EL, Angulo D, Lockhart SR. In Vitro Activity of a Novel Glucan Synthase Inhibitor, SCY-078, against Clinical Isolates of Candida auris. Antimicrob Agents Chemother. 2017 Jun 27;61(7). pii: e00435-17. doi: 10.1128/AAC.00435-17. Print 2017 Jul.
- Larkin E, Hager C, Chandra J, Mukherjee PK, Retuerto M, Salem I, Long L, Isham N, Kovanda L, Borroto-Esoda K, Wring S, Angulo D, Ghannoum M. The Emerging Pathogen Candida auris: Growth Phenotype, Virulence Factors, Activity of Antifungals, and Effect of SCY-078, a Novel Glucan Synthesis Inhibitor, on Growth Morphology and Biofilm Formation. Antimicrob Agents Chemother. 2017 Apr 24;61(5). pii: e02396-16. doi: 10.1128/AAC.02396-16. Print 2017 May.
- SCY-078-305