SCYNEXIS to Present Data on Oral Ibrexafungerp at IDWeek 2021 from Interim Analyses of Phase 3 FURI Clinical Trial Showing Therapeutic Response Rates in Patients with Mucocutaneous and Invasive Fungal Infections

Rhea-AI Summary

SCYNEXIS, Inc. announced presentations of interim data from its Phase 3 FURI study at IDWeek 2021, focusing on ibrexafungerp for treating refractory fungal infections. The study includes 74 patients, highlighting outcomes for infections caused by Candida, especially drug-resistant strains. This is significant as invasive fungal infections are challenging to treat due to rising antifungal resistance. The company aims to make ibrexafungerp available to patients globally, following its FDA approval for BREXAFEMME in June 2021.

Positive

• Presentation of interim data indicating ibrexafungerp's effectiveness against drug-resistant fungal infections.
• Successful FDA approval of BREXAFEMME (ibrexafungerp) on June 1, 2021, for broader patient access.

Negative

• None.

Analysis of subpopulations from a total of 74 patients evaluated to date from FURI includes outcomes by disease, bone and joint infections, and mouth and throat candidiasis

JERSEY CITY, N.J., Sept. 23, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced one oral and two poster presentations of interim data from its Phase 3 FURI study, evaluating oral ibrexafungerp for the treatment of patients with refractory mucocutaneous and invasive fungal infections, will be presented at IDWeek 2021, the premier U.S. meeting of leaders in the field of infectious diseases taking place virtually September 29 – October 3.

“Patients with invasive fungal infections often require extensive therapy over weeks or months and have limited oral treatment options which presents a significant challenge to care especially given the persistent rise of antifungal resistance to current medications,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “The data from these three presentations provide a deeper understanding of ibrexafungerp’s activity against a broad spectrum of fungal infections caused by Candida species, including azole- and echinocandin-resistant strains. We are encouraged by the interim results of the study as we work toward the goal of making ibrexafungerp available to patients with serious fungal infections in the U.S. and around the world.”

IDWeek is the joint annual gathering of representatives from the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP).

Recorded presentations will be accessible to meeting attendees via the IDWeek Interactive Program Site. Presentation details:

• Oral Ibrexafungerp Outcomes by Fungal Disease in Patients from an Interim Analysis of a Phase 3 Open-label Study (FURI) – Peter G. Pappas, M.D., University of Alabama at Birmingham (UAB)
  Oral Abstract Presentation – New Findings in Medical Mycology: O-25
  

• Oral Ibrexafungerp Outcomes in Patients with Oropharyngeal Candidiasis and Esophageal Candidiasis from an Interim Analysis of a Phase 3 Open-label Study (FURI) – Jose A. Vazquez, M.D., FACP, FIDSA, Augusta University
  Poster Presentation – Medical Mycology: 992
  

• Outcomes of Candida Bone and Joint Infections in Eight Patients from a Phase 3 Open-label Study (FURI) – John Walton Sanders III, MD, MPH, Wake Forest Baptist Health
  Poster Presentation – Medical Mycology: 983
  

For more information on the Phase 3 FURI study, visit ClinicalTrials.gov (NCT03059992).

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME^® (ibrexafungerp tablets) on June 1, 2021. The FDA also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME^® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent Vulvovaginal Candidiasis (VVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com. 

CONTACT: 

Investor Relations
Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681 (w)
ikoffler@lifesciadvisors.com

Media Relations
Gloria Gasaatura
LifeSci Communications
646-970-4688
ggasaatura@lifescicomms.com

FAQ

What were the key findings from the FURI study presented by SCYNEXIS at IDWeek 2021?

The interim analysis presented outcomes for patients with refractory fungal infections, demonstrating ibrexafungerp's effectiveness against a range of Candida species, including drug-resistant strains.

When was ibrexafungerp FDA approved and what is its significance for SCYNEXIS?

Ibrexafungerp was FDA approved on June 1, 2021, allowing SCYNEXIS to provide a novel treatment option for patients facing drug-resistant fungal infections.

How many patients were evaluated in the FURI study?

A total of 74 patients were evaluated in the FURI study to date.

What is the future direction for SCYNEXIS after the IDWeek presentations?

SCYNEXIS aims to make ibrexafungerp available to patients worldwide while continuing its late-stage clinical investigations.