1248 - Efficacy and Safety of Oral Ibrexafungerp in 41 Patients with Refractory Fungal Diseases, Interim Analysis of a Phase 3 Open-label Study (FURI)

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Presenting Author(s)

Barbara D. Alexander

Professor of Medicine, Professor of Pathology
Duke University School of Medicine
Durham, North Carolina
Disclosure: SCYNEXIS, Inc. (Employee, Scientific Research Study Investigator, Research Grant or Support)

Co-Author(s)

OC

Oliver A. Cornely

Prof.
University of Cologne, Faculty of Medicine and University Hospital Cologne
Cologne, Nordrhein-Westfalen, Germany
Disclosure: Actelion (Grant/Research Support)Actelion (Other Financial or Material Support, Personal fees)Al Jazeera Pharmaceuticals (Consultant)Allecra Therapeutics (Other Financial or Material Support, Personal fees)Amplyx (Other Financial or Material Support, Personal fees)Amplyx (Grant/Research Support)Astellas (Grant/Research Support)Astellas (Other Financial or Material Support, Personal fees)Basilea (Other Financial or Material Support, Personal fees)Basilea (Grant/Research Support)Biosys UK Limited (Other Financial or Material Support, Personal fees)Cidara (Other Financial or Material Support, Personal fees)Cidara (Grant/Research Support)Da Volterra (Grant/Research Support)Da Volterra (Other Financial or Material Support, Personal fees)Entasis (Other Financial or Material Support, Personal fees)F2G (Other Financial or Material Support)F2G (Grant/Research Support)Gilead (Grant/Research Support)Gilead (Other Financial or Material Support, Personal fees)Grupo Biotoscana (Other Financial or Material Support, Personal fees)Janssen Pharmaceuticals (Grant/Research Support)Matinas (Other Financial or Material Support, Personal fees)Medicines Company (Grant/Research Support)MedPace (Grant/Research Support)MedPace (Other Financial or Material Support, Personal fees)Melinta Therapeutics (Grant/Research Support)Menarini Ricerche (Other Financial or Material Support, Personal fees)Merck/MSD (Other Financial or Material Support, Personal fees)Merck/MSD (Grant/Research Support)Mylan Pharmaceuticals (Consultant)Nabriva Therapeutics (Other Financial or Material Support, Personal fees)Octapharma (Other Financial or Material Support, Personal fees)Paratek Pharmaceuticals (Other Financial or Material Support, Personal fees)Pfizer (Other Financial or Material Support, Personal fees)Pfizer (Grant/Research Support)PSI (Other Financial or Material Support, Personal fees)Rempex (Other Financial or Material Support, Personal fees)Roche Diagnostics (Other Financial or Material Support, Personal fees)Scynexis (Other Financial or Material Support, Personal fees)Scynexis (Grant/Research Support)Seres Therapeutics (Other Financial or Material Support, Personal fees)Tetraphase (Other Financial or Material Support, Personal fees)
PP

Peter G. Pappas

Emeritus Professor of Medicine
University of Alabama at Birmingham
Birmingham, AL
Disclosure: SCYNEXIS, Inc. (Consultant, Advisor or Review Panel member, Research Grant or Support)
RM

Rachel Miller

Professor of Medicine
Duke University
Durham, North Carolina
Disclosure: SCYNEXIS, Inc. (Scientific Research Study Investigator)
Jose A. Vazquez

Professor of Medicine
Medical College of Georgia at Augusta University
Augusta, GA
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
LO

Luis Ostrosky-Zeichner

Professor of Medicine
McGovern Medical School. UTHealth
Texas, Texas
Disclosure: Amplyx (Scientific Research Study Investigator)Astellas (Consultant, Scientific Research Study Investigator, Other Financial or Material Support, Non-branded educational speaking)Biotoscana (Consultant, Other Financial or Material Support, Non-branded educational speaking)Cidara (Consultant, Scientific Research Study Investigator)F2G (Consultant)Gilead (Consultant)Mayne (Consultant)Octapharma (Consultant)Pfizer (Other Financial or Material Support, Non-branded educational speaking)Scynexis (Consultant, Grant/Research Support, Scientific Research Study Investigator)Stendhal (Consultant)Viracor (Consultant)
AS

Andrej Spec

Asst. Professor of Medicine
Washington University, St. Louis
St. Louis, Missouri
Disclosure: SCYNEXIS, Inc. (Scientific Research Study Investigator, Advisor or Review Panel member)
RR

Riina Rautemaa-Richardson

Clinical Senior Lecturer
University of Manchester
Manchester, England, United Kingdom
Disclosure: SCYNEXIS, Inc. (Scientific Research Study Investigator)
RK

Robert Krause

Head of the Section of Infectious and Tropical Medicine
Medical University, Graz
Graz, Steiermark, Austria
Disclosure: SCYNEXIS, Inc. (Scientific Research Study Investigator)
George R. Thompson

Associate Professor of Medicine
UC-Davis
Sacramento, California
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CM

Caryn Morse

Associate Professor of Medicine
Wake Forest Baptist Hospital
Winston-Salem, North Carolina
Disclosure: SCYNEXIS, Inc. (Scientific Research Study Investigator)
John W. Sanders

Professor and Section Chief
Wake Forest University School of Medicine
Winston-Salem, North Carolina
Disclosure: SCYNEXIS, Inc. (Scientific Research Study Investigator)
David Andes

Professor
University of Wisconsin
Madison, Wisconsin
Disclosure: SCYNEXIS, Inc. (Scientific Research Study Investigator, Advisor or Review Panel member)
GL

George Lyon

Professor of Medicine
Emory Health
Atlanta, Georgia
Disclosure: SCYNEXIS, Inc. (Scientific Research Study Investigator)
Francisco M. Marty

Associate Professor
Brigham and Women's Hospital
Boston, Massachusetts
Disclosure: Allovir (Consultant)Amplyx (Consultant)Ansun (Scientific Research Study Investigator)Avir (Consultant)Cidara (Scientific Research Study Investigator)F2G (Consultant, Scientific Research Study Investigator)Kyorin (Consultant)Merck (Consultant, Grant/Research Support, Scientific Research Study Investigator)New England Journal of Medicine (Other Financial or Material Support, Honorarium for Video)Regeneron (Consultant, Scientific Research Study Investigator)ReViral (Consultant)Scynexis (Scientific Research Study Investigator)Symbio (Consultant)Takeda (Scientific Research Study Investigator)United Medical (Consultant)WHISCON (Scientific Research Study Investigator)
ES

Emily Silverman

Research Coordinator
Dana-Farber Cancer Institute
Boston, Massachusetts
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Marisa H. Miceli

Associate Professor
University of Michigan
Ann Arbor, Michigan
Disclosure: SCYNEXIS, Inc. (Advisor or Review Panel member)
Thomas F. Patterson

Professor and Chief, Infectious Diseases
University of Texas Health San Antonio
San Antonio, TX
Disclosure: SCYNEXIS, Inc. (Advisor or Review Panel member)
MH

Martin Hoenigl

Ass Prof
University of California, San Diego
San Diego, CA
Disclosure: SCYNEXIS, Inc. (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)
Nkechi Azie

VP, Clinical Development
SCYNEXIS, Inc.
Jersey City, NJ
Disclosure: SCYNEXIS, Inc. (Employee, Shareholder)
DA

David A. Angulo

Chief Medical Officer
SCYNEXIS, Inc.
Jersey City, New Jersey
Disclosure: SCYNEXIS, Inc. (Employee, Shareholder)

Background: Candida infections resistant to currently available antifungals are an emerging global threat. Ibrexafungerp is an investigational broad-spectrum glucan synthase inhibitor antifungal with activity against Candida and Aspergillus species, including azole- and echinocandin-resistant strains. A Phase 3 open-label, single-arm study of oral ibrexafungerp (FURI) (Clinicaltrials.gov NCT03059992) is ongoing for the treatment of patients (≥18 years) with fungal diseases who are intolerant of or refractory to standard antifungal therapies.

Methods: An independent Data Review Committee (DRC) provided an assessment of treatment response for 41 patients. Patients were enrolled in 22 centers from 6 countries. Patients were eligible for enrollment if they had proven or probable, invasive or severe mucocutaneous candidiasis and documented evidence of failure of, intolerance to, or toxicity related to a currently approved standard-of-care antifungal treatment or could not receive approved oral antifungal options (e.g., susceptibility of the organism) and a continued IV antifungal therapy was undesirable or unfeasible.

Results: The 41 patients assessed had the following infection types: intra-abdominal abscesses, oropharyngeal candidiasis, esophageal candidiasis, candidemia, and others. The DRC adjudicated 23 patients (56%) as achieving complete or partial response, 11 patients (27%) maintaining stable disease, 6 patients (15%) with progression of disease and one case was considered as indeterminate. The efficacy of oral ibrexafungerp by pathogen is shown in Table 1. Ibrexafungerp was well-tolerated with the most common treatment-related adverse events being of gastrointestinal origin. No deaths due to progression of fungal disease were reported.Table 1: Ibrexafungerp Outcomes by Pathogen

Conclusion: Preliminary analysis of these 41 cases indicate that oral ibrexafungerp provides a favorable therapeutic response in the majority of patients with difficult to treat Candida spp. infections, including those caused by non-albicans Candida species.