Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)

Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 (Ibrexafungerp) in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.

Study Overview

• Status: Completed
• Conditions: Coccidioidomycosis; Invasive Pulmonary Aspergillosis; Allergic Bronchopulmonary Aspergillosis; Histoplasmosis; Chronic Pulmonary Aspergillosis; Blastomycosis; Invasive Candidiasis; Recurrent Vulvovaginal Candidiasis; Mucocutaneous Candidiasis; Other Emerging Fungi
• Intervention / Treatment: Drug: Ibrexafungerp

Detailed Description

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp in patients ≥ 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Patients will be treated with ibrexafungerp for up to 180 days. Treatment beyond 180 days and combination therapy with other antifungal agents may be allowed under special circumstances to be agreed upon by the Investigator and the Sponsor.

Subjects must have a proven or probable fungal disease and meet all study criteria to be considered for enrollment. Eligible subjects must also have documented evidence of failure of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment.

Subjects will also be considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, the subject cannot receive approved oral antifungal options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstances.

Following a screening visit, there will be up to 15 treatment visits, a follow-up visit and 2 follow-up contacts.

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nkechi Azie, MD; Phone Number: 201-688-2243; Email: nkechi.azie@scynexis.com
• Study Contact Backup: Name: Kristin Bennett; Phone Number: 201-884-5469; Email: kristin.bennett@scynexis.com

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine
  • Innsbruck, Austria, 6020
    • Medical University Innsbruck
• Germany
  • Cologne, Germany, 50937
    • Universitatsklinikum Koln, Klinik I fur Innere Medizin
  • Essen, Germany, 45147
    • Universitätsklinikum Essen, Klinik für Infektiologie
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt, Department of Internal Medicine II
  • Leipzig, Germany, 04129
    • Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology
  • Munich, Germany, 81377
    • LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525
      • Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8
• Pakistan
  • Karachi, Pakistan, 74800
    • Aga Khan University
• South Africa
  • Centurion
    • Lyttelton, Centurion, South Africa, 0154
      • Johese Clinical Research
  • Pretoria
    • Groenkloof, Pretoria, South Africa, 0181
      • Into Research
    • Muckleneuck, Pretoria, South Africa, 0002
      • Emmed Research
  • Vereeniging
    • Three Rivers, Vereeniging, South Africa, 1935
      • FCRN Clinical Trial Centre
• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
• United Kingdom
  • London, United Kingdom, SW17 0RE
    • St. George's University of London
  • Manchester, United Kingdom, M13 9PL
    • The University of Manchester
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0006
      • University of Alabama at Birmingham
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital Midtown
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15203
      • University of Pittsburg Medical Center
  • Texas
    • Dallas, Texas, United States, 75390-8589
      • University of Texas Southwestern Medical Center Dallas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

1. Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment
2. Be able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube
3. Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
4. Be able to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information. (e.g., in the U.S. HIPAA Authorization form).
5. Be able to understand and follow all study-related procedures including study drug administration.
6. Agree to use a medically acceptable method of contraception while receiving protocol-assigned product.

Key Exclusion Criteria:

1. An invasive fungal disease with CNS involvement.
2. Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters that cannot be removed and are likely the source of infection).
3. Subject is hemodynamically unstable, requiring vasopressor medication for blood pressure support.
4. A life expectancy < 30 days.
5. Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >10 x the upper limit of normal (ULN), and/or total bilirubin > 5 x ULN.
6. Subject is pregnant or lactating.
7. Subject has used an investigational drug within 30 days prior to the baseline visit.

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: Ibrexafungerp (SCY-078); Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.	Drug: Ibrexafungerp; Experimental Study Drug; Other Names: SCY-078

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Global Response	The proportion of subjects with a complete or partial Global Response (GR) at the End of Treatment Visit.	Up to 180 days of study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Recurrence of Baseline Fungal Infection	The proportion of subjects with a recurrence of the baseline fungal infectoin	up to 42 days after end of study treatment
Assessment of survival	Proportion of surviving subjects	Day 42, Day 84

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Davis MR, Donnelley MA, Thompson GR. Ibrexafungerp: A novel oral glucan synthase inhibitor. Med Mycol. 2020 Jul 1;58(5):579-592. doi: 10.1093/mmy/myz083.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): August 17, 2023
• Study Completion (Actual): August 17, 2023

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Bacterial Infections and Mycoses; Parasitic Diseases; Protozoan Infections; Skin Diseases, Infectious; Respiratory Hypersensitivity; Hypersensitivity; Invasive Fungal Infections; Dermatomycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Lung Diseases, Fungal; Vulvitis; Vulvovaginitis; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Candidiasis; Candidiasis, Invasive; Mycoses; Aspergillosis; Pulmonary Aspergillosis; Invasive Pulmonary Aspergillosis; Candidiasis, Vulvovaginal; Aspergillosis, Allergic Bronchopulmonary; Histoplasmosis; Blastomycosis; Coccidioidomycosis; Coccidiosis; Candidiasis, Chronic Mucocutaneous; Anti-Infective Agents; Antifungal Agents; Ibrexafungerp
• Other Study ID Numbers: SCY-078-301; 2017-000381-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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