SCYNEXIS to Present Positive Interim Data from the Phase 3 FURI Study of Oral Ibrexafungerp at IDWeek 2022

Rhea-AI Summary

SCYNEXIS, Inc. (NASDAQ: SCYX) announced that interim data from the Phase 3 FURI study on oral ibrexafungerp will be presented at IDWeek 2022 in Washington, D.C., from October 19-23, 2022. The presentations will cover all-cause mortality in patients with invasive candidiasis and outcomes by fungal disease, emphasizing ibrexafungerp's potential in treating drug-resistant infections. Ibrexafungerp, a novel antifungal agent, is in late-stage development for severe fungal infections and received multiple designations from the FDA and EMA to expedite its path to market.

Positive

• Ibrexafungerp shows promise in treating drug-resistant fungal infections.
• Multiple FDA and EMA designations enhance development prospects.
• Presentations at IDWeek 2022 may increase visibility and investor interest.

Negative

• The need for ongoing clinical trials indicates that market approval is not yet guaranteed.

JERSEY CITY, N.J., Oct. 11, 2022 (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 that interim data from the Phase 3 FURI study of oral ibrexafungerp for the treatment of patients intolerant of, or with fungal disease refractory to, standard antifungal therapy will be presented during IDWeek 2022 being held in Washington, D.C October 19-23, 2022.

Title: All-Cause Mortality in Patients with Invasive Candidiasis or Candidemia from an Interim Analysis of a Phase 3 Open-label Study (FURI)
Format: Poster
Presenter: Jurgen Prattes, MD, University of Graz
Session: Medical Mycology
Date/Time: Thursday October 20, 2022, 12:15 PM - 1:30 PM EDT
Location: Walter E. Washington Convention Center in Exhibit Hall BC

Title: Oral Ibrexafungerp Outcomes by Fungal Disease in Patients from an Interim Analysis of a Phase 3 Open-label Study (FURI)
Format: Oral Presentation
Presenter: George Thompson, MD, University of California, Davis
Session: Antifungal Clinical Trials & PK/PD Studies
Date/Time: Friday October 21, 2022, 10:30 AM – 11:45 AM EDT
Location: Walter E. Washington Convention Center in 147 AB

Title: Ibrexafungerp Update
Format: Oral Presentation
Presenter: Nkechi Azie, MD, MBA, FDISA, SCYNEXIS
Session: New Antimicrobials and ID Diagnostics in the Pipeline – Fungal
Date/Time: Saturday October 22, 2022, 8:00 AM – 8:10 AM EDT
Location: Walter E. Washington Convention Center in 145 AB

For more information, see the IDWeek 2022 website here.

About Ibrexafungerp

Ibrexafungerp 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 FDA 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. The European Medicines Agency (EMA) has granted ibrexafungerp Orphan Medicinal Product designation for the indication of IC. 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 oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.

CONTACT: 

Investors:
Irina Koffler
LifeSci Advisors
ikoffler@lifesciadvisors.com

Media:
Debbie Etchison
debbie.etchison@scynexis.com

FAQ

What are the key findings from the Phase 3 FURI study presented by SCYNEXIS?

The Phase 3 FURI study presents interim data on oral ibrexafungerp's efficacy in treating invasive candidiasis and candidemia.

When will SCYNEXIS present data from the FURI study?

Data will be presented at IDWeek 2022 in Washington, D.C., on October 20 and 21, 2022.

What designations has ibrexafungerp received from the FDA?

Ibrexafungerp received Qualified Infectious Disease Product (QIDP) and Fast Track designations.

What is the significance of ibrexafungerp's presentations at IDWeek 2022?

The presentations can raise awareness and credibility for ibrexafungerp as a treatment for difficult-to-treat fungal infections.