Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) (CARES)

• ClinicalTrials.gov Identifier: NCT03363841
• Recruitment Status: Recruiting
• First Posted: December 6, 2017
• Last Update Posted: September 1, 2020
• Sponsor: Scynexis, Inc.
• Information provided by (Responsible Party): Scynexis, Inc.

Tracking Information

• First Submitted Date: November 14, 2017
• First Posted Date: December 6, 2017
• Last Update Posted Date: September 1, 2020
• Actual Study Start Date: November 15, 2017
• Estimated Primary Completion Date: November 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 4, 2017)

Efficacy as measured by the percentage of subjects with global success at end of treatment [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 4, 2017)

• Number of participants with treatment-related Adverse Events (Safety) [ Time Frame: 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) [ Time Frame: Through study completion, an average of 132 days ]
  Number of participants with Discontinuations due to Adverse Events
• Recurrence of Baseline Fungal Infection (Efficacy) [ Time Frame: 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) [ Time Frame: Day 42 and Day 84 ]
  Proportion of surviving subjects

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
• Official Title: Open-Label Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral Ibrexafungerp (SCY-078) as an Emergency Use Treatment for Patients With Candidiasis, Including Candidemia, Caused by Candida Auris
• 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.

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 Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

non comparator, single arm

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Candidiasis, Invasive
• Candidemia

Intervention

Drug: SCY-078

Oral SCY-078

Study Arms

Experimental: SCY-078

SCY-078

Intervention: Drug: SCY-078

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 4, 2017): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 15, 2021
• Estimated Primary Completion Date: November 15, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject must fulfill the following KEY criteria to be eligible for study admission:

  1. Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed.
  2. 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.
  3. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.

Exclusion Criteria:

• KEY exclusion criteria:

  1. Subject has a fungal disease with central nervous system involvement.
  2. Subject has a fungal disease of the bone and/or joint that is expected to require >90 days of study drug treatment.
  3. Subject has an inappropriately controlled fungal infection source (e.g., persistent catheters, devices, identified abscess) that is likely the source of the fungal infection.
  4. Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support.
  5. 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.
  6. Subject has an Apache score >16.
  7. Subject has serum creatinine >3 times from Baseline (Screening/Treatment Day 1) value.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: David Angulo, MD; 201-884-5471; david.angulo@scynexis.com

Contact: Mihaela Tufa, MD; 201-884-5899; mihaela.tufa@scynexis.com

• Listed Location Countries: India, Pakistan, South Africa, United States

Administrative Information

• NCT Number: NCT03363841
• Other Study ID Numbers: SCY-078-305
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Scynexis, Inc.
• Study Sponsor: Scynexis, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: David Angulo, MD; Scynexis, Inc.

• PRS Account: Scynexis, Inc.
• Verification Date: August 2020