SCYNEXIS to Present New Data of Ibrexafungerp for Refractory Vulvovaginal Candidiasis from Ongoing Phase 3 FURI Study at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting

Rhea-AI Summary

SCYNEXIS, Inc. (NASDAQ: SCYX) announced a product theater presentation scheduled for May 7, 2022, at the ACOG Annual Meeting in San Diego. The focus will be on clinical data from the ongoing FURI study of ibrexafungerp, the first new antifungal class approved in over 25 years. The presentation will include outcomes from an open-label study addressing refractory vulvovaginal candidiasis. Ibrexafungerp shows promise as a broad-spectrum systemic antifungal, with FDA approvals and orphan drug designations supporting its innovative approach to treating drug-resistant infections.

Positive

• Participation in the ACOG Annual Meeting highlights SCYNEXIS's commitment to women's health.
• New data from the FURI study could enhance the understanding of ibrexafungerp's efficacy.
• Ibrexafungerp is the first new antifungal class in over 25 years, indicating a significant advancement in treatment options.
• FDA approval and orphan drug designations for ibrexafungerp underline its potential market impact and importance.

Negative

• None.

Product theater presentation will be held on May 7 to highlight clinical data and attributes of the first new antifungal class approved in more than 25 years

JERSEY CITY, N.J., May 04, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, will present new data from its ongoing FURI study of ibrexafungerp during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting being held in San Diego, May 6-8, 2022.

“We are excited to attend this important meeting, which brings together many of the top medical minds in the OB/GYN field,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We look forward to sharing details about our latest advancements in the area of women’s health.”

Poster Presentation:

Title: Oral Ibrexafungerp Outcomes in Subjects with Refractory Vulvovaginal Candidiasis from an Open-label Study (FURI)
Poster Session B
Date/Time: May 6, 2022/1:00 p.m. – 2:00 p.m. PT
Location: San Diego Convention Center, Hall E
Poster: A122
Presenter: Tosin Goje M.D., MSCR, FACOG

Product Theater:

Title: A Novel Treatment to Meet the Evolving Challenge of Vulvovaginal Candidiasis
Date: Saturday, May 7, 2022
Time: 7:00 a.m. – 7:30 a.m. PT
Location: San Diego Convention Center, Room 6C
Presenter: Michael L. Krychman, M.D.

For more information, see the ACOG website here.

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. 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, clinical investigation and development of oral 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
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com

Media Relations
Brett Whelan
LifeSci Communications
Tel: (339) 368-0466
bwhelan@lifescicomms.com

 

FAQ

What is the purpose of SCYNEXIS's FURI study?

The FURI study aims to evaluate the efficacy of ibrexafungerp in treating refractory vulvovaginal candidiasis.

When will the product theater presentation take place?

The product theater presentation is scheduled for May 7, 2022, from 7:00 a.m. to 7:30 a.m. PT.

What is ibrexafungerp and why is it significant?

Ibrexafungerp is an antifungal agent that represents the first new class of antifungals in over 25 years, showing broad-spectrum activity against drug-resistant infections.

What are the FDA designations received for ibrexafungerp?

Ibrexafungerp has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.