Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults

The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

Study Overview

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

Detailed Description

Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• El Salvador
  • San Salvador, El Salvador
    • Hospital Militar Central
  • San Salvador, El Salvador
    • Hospital Rosales
• Germany
  • North Rhine Westphalia
    • Cologne, North Rhine Westphalia, Germany
      • University of Cologne
• Guatemala
  • Guatemala, Guatemala, Zona 16
    • Finca El Palomar
• Honduras
  • Cortes
    • San Pedro Sula, Cortes, Honduras
      • Hospital Mario Catarino Rivas
    • San Pedro Sula, Cortes, Honduras
      • Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University School of Medicine
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • Dallas, Texas, United States, 75235
      • Parkland Hospital
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
    • San Antonio, Texas, United States, 78229
      • South Texas Veterans Healthcare System
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
• Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.

Exclusion Criteria:

• Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
• Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
• Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
• Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCY-078 500 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.	Drug: SCY-078
Experimental: SCY-078 750 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.	Drug: SCY-078
Active Comparator: Standard-of-care; Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.	Drug: Fluconazole; Drug: Micafungin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements	All Related TEAEs by SOC and PT, by Treatment, Safety	up to 10 weeks
Dose of SCY-078 That Achieves the Target Exposure (AUC)	Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK	0 to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Response	Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture)	end of all antifungal therapy (administered for a maximum of 28 days)
Clinical Response	Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy	end of all antifungal therapy (administered for a maximum of 28 days)
Microbiological Response	Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection	end of all antifungal therapy (administered for a maximum of 28 days)
Relapse	If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered	2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimated): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Micafungin; Fluconazole; Candidemia; Invasive Candidiasis; Invasive Candida infections; SCY-078; Echinocandin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Sepsis; Invasive Fungal Infections; Fungemia; Candidiasis; Candidemia; Candidiasis, Invasive; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Micafungin; Fluconazole; Ibrexafungerp
• Other Study ID Numbers: SCY-078-202