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

NCT03363841 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: SCY-078-305
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 12

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.

Conditions

Candidiasis, Invasive; Candidemia

Keywords

Candida auris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percent of Participants With Treatment-emergent Adverse Events

  Through study completion, up to 132 days

• Number of Participants Discontinued Due to Adverse Events

  Through study completion (up to 132 Days)

• Percentage of Participants With Recurrence of Baseline Fungal Infection

  42 Days after the End of Treatment visit

• Percentage of Participants Surviving 42 and 84 Days

  Day 42 and Day 84 after first dose of study drug

Study Arms (1)

SCY-078

EXPERIMENTAL

SCY-078

Drug: SCY-078

Interventions

SCY-078 DRUG

Oral SCY-078

SCY-078

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scynexis, Inc.: lead

Study Sites (12)

Scynexis, Inc.

Jersey City, New Jersey, 07302, United States

Location

St John's Medical College and Hospital

Bangalore, Karnataka, 560034, India

Location

Amrita Institute of Medical Sciences (AIMS)

Kanayannur, Kochi, 682041, India

Location

Institute of Critical Care Medicine Max Super Specialty Hospital

Saket, New Delhi, 110017, India

Location

King George Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care

Chandigarh, 160012, India

Location

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157

Centurion, Gauteng, 0157, South Africa

Location

Emmed Research, Jakarta Hospital

Pretoria, Gauteng, 0002, South Africa

Location

Into Research, Life Groenkloof Hospital

Pretoria, Gauteng, 0181, South Africa

Location

Johese Clinical Research, Midstream

Pretoria, Gauteng, 1692, South Africa

Location

Zuid Afrikaans Hospital

Pretoria, 0002, South Africa

Location

Related Publications (2)

• 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.

  PMID: 28483955 BACKGROUND

• 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.

  PMID: 28223375 BACKGROUND

MeSH Terms

Conditions

Candidiasis, Invasive; Candidemia

Interventions

ibrexafungerp

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Angulo
• Organization: Scynexis

David.Angulo@scynexis.com

201-884-5471

Study Officials

• David Angulo, MD

  Scynexis, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: non comparator, single arm

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 6, 2017
• Study Start: November 15, 2017
• Primary Completion: April 14, 2023
• Study Completion: May 24, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Locations

PA (1); ZA (5); US (1); IN (5)