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

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

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.

Study Overview

• Status: Completed
• Conditions: Candidemia; Candidiasis, Invasive
• Intervention / Treatment: Drug: SCY-078

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
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care
  • Karnataka
    • Bangalore, Karnataka, India, 560034
      • St John's Medical College and Hospital
  • Kochi
    • Kanayannur, Kochi, India, 682041
      • Amrita Institute of Medical Sciences (AIMS)
  • New Delhi
    • Saket, New Delhi, India, 110017
      • Institute of Critical Care Medicine Max Super Specialty Hospital
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • King George Medical University
• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Aga Khan University Hospital
• South Africa
  • Pretoria, South Africa, 0002
    • Zuid Afrikaans Hospital
  • Gauteng
    • Centurion, Gauteng, South Africa, 0157
      • Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157
    • Pretoria, Gauteng, South Africa, 0002
      • Emmed Research, Jakarta Hospital
    • Pretoria, Gauteng, South Africa, 0181
      • Into Research, Life Groenkloof Hospital
    • Pretoria, Gauteng, South Africa, 1692
      • Johese Clinical Research, Midstream
• United States
  • New Jersey
    • Jersey City, New Jersey, United States, 07302
      • Scynexis, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCY-078	Drug: SCY-078; Oral SCY-078

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee	The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.	At (EoT) Visit (up to 90 days after Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants With Treatment-emergent Adverse Events	Percent of participants with treatment-emergent Adverse Events (TEAEs)	Through study completion, up to 132 days
Number of Participants Discontinued Due to Adverse Events	Number of participants with Discontinuations due to Adverse Events	Through study completion (up to 132 Days)
Percentage of Participants With Recurrence of Baseline Fungal Infection	The percentage of participants with a recurrence of the baseline fungal infection at the 6 week follow-up	42 Days after the End of Treatment visit
Percentage of Participants Surviving 42 and 84 Days	Percentage of participants Surviving at Day 42 and Day 84 after Day 1 (first dose of study drug)	Day 42 and Day 84 after first dose of study drug

Collaborators and Investigators

• Sponsor: Scynexis, Inc.
• Investigators: Study Director: David Angulo, MD, Scynexis, Inc.

Publications and helpful links

General 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):e00435-17. doi: 10.1128/AAC.00435-17. Print 2017 Jul. No abstract available.
• 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):e02396-16. doi: 10.1128/AAC.02396-16. Print 2017 May.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): April 14, 2023
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Candida auris
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Sepsis; Mycoses; Invasive Fungal Infections; Fungemia; Candidiasis; Candidemia; Candidiasis, Invasive; Anti-Infective Agents; Antifungal Agents; Ibrexafungerp
• Other Study ID Numbers: SCY-078-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No