SCYNEXIS to Present Two Ibrexafungerp (Brexafemmeᵀᴹ) Posters at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting

Rhea-AI Summary

SCYNEXIS (NASDAQ: SCYX) announced that two data sets from its Phase 3 VANISH Program on ibrexafungerp for vulvovaginal candidiasis (VVC) have been accepted for poster presentations at the ACOG Annual Meeting from April 30 to May 2, 2021. Brexafemme, the trade name for ibrexafungerp, is under FDA review with a PDUFA date set for June 1, 2021. The posters will feature studies on non-albicans Candida species and the efficacy and safety of the treatment. If approved, Brexafemme will be the first novel antifungal class in over 20 years, addressing an urgent need in VVC treatment.

JERSEY CITY, N.J., April 20, 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 that two data sets from the Company’s Phase 3 VANISH Program evaluating ibrexafungerp as a treatment for vulvovaginal candidiasis (VVC), also known as vaginal yeast infection, were accepted for poster presentations at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting, to be held virtually from April 30 – May 2, 2021. Brexafemme, the expected trade name for ibrexafungerp, is a one-day oral antifungal treatment for VVC under regulatory review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date set for June 1, 2021.

Presentation details:

Title:	Phase 3 Oral Ibrexafungerp Study in Vulvovaginal Candidiasis (VANISH-303): Outcomes in Non-albicans Candida spp.
Poster #:	ID961398
Authors:	Dr. Nkechi Azie, Dr. David Angulo, Dr. Paul Nyirjesy
Title:	Efficacy and Safety of Oral Ibrexafungerp in the Treatment of Vulvovaginal Candidiasis: A Phase 3 Study (VANISH-306)
Poster #: Authors:	ID957079 Dr. Nkechi Azie, Dr. David Angulo, Dr. Ryan Sobel

All posters will be live via the ACOG virtual meeting platform starting April 30^th at 11 am ET. Register to attend via Link.

The posters will be made be available for three months and can be found on the SCYNEXIS website at: https://www.scynexis.com/news-media/events

About Brexafemme™ (ibrexafungerp)
Brexafemme is an oral antifungal product candidate under regulatory review for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Its mechanism of action, glucan synthase inhibition, is fungicidal against Candida species, meaning it kills fungal cells. A New Drug Application (NDA) for Brexafemme is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021. The NDA is supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated statistically superior efficacy and a favorable tolerability profile in women with VVC. If approved, Brexafemme would represent the first novel antifungal class in over 20 years and would be the first and only non-azole treatment for vaginal yeast infections.

About Vulvovaginal Candidiasis
VVC, commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis. Although these infections are frequently caused by Candida albicans, infections caused by fluconazole-resistant and non-albicans Candida strains, such as Candida glabrata, have been reported to be on the rise. VVC can be associated with substantial morbidity, including significant genital discomfort (pain, itching, burning), reduced sexual pleasure and activity, psychological distress (stress, depression, anxiety), embarrassment, reduced physical activity, and loss of productivity. Typical VVC symptoms include pruritus, vaginal soreness, irritation, excoriation of vaginal mucosa and abnormal vaginal discharge. An estimated 70-75% of women worldwide will have at least one episode of VVC in their lifetime, and 40-50% of them will experience multiple episodes.

Current treatments for VVC include several topical azole antifungals and oral fluconazole, which is the only orally administered antifungal currently approved for the treatment of VVC in the U.S. and which accounts for over 90% of the prescriptions written each year. Fluconazole reported a 55% therapeutic cure rate in its label, which now also includes warnings of potential fetal harm, illustrating the need for new oral alternatives. In addition, there are many women who do not respond to or do not tolerate fluconazole, such as women with persistent (“chronic”) infections, recurrent infections (four or more recurrences in a 12-month period), Non-albicans / azole-resistant Candida strains (e.g., Candida glabrata), diabetic patients, especially with poorly controlled glycemia, and obese patients. These women could benefit from a non-azole, and preferably, oral treatment option.

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. Our lead candidate, ibrexafungerp (formerly known as SCY-078), is a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, currently under regulatory review for the treatment of vaginal yeast infection, also known as vulvovaginal candidiasis (VVC), and in late-stage development for the treatment of life-threatening fungal infections in hospitalized patients. The SCYNEXIS team has deep expertise in anti-infective drug development and marketing, which can be leveraged to advance ibrexafungerp from clinical development to commercialization. For more information, visit www.scynexis.com.

CONTACT: 
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com

Media Relations
Gloria Gasaatura
LifeSci Communications
Tel: (646) 970-4688
ggasaatura@lifescicomms.com

FAQ

What are the details of SCYNEXIS' presentations at the ACOG Annual Meeting regarding SCYX?

SCYNEXIS will present two data sets from its Phase 3 VANISH Program on ibrexafungerp for vulvovaginal candidiasis at the ACOG Annual Meeting from April 30 to May 2, 2021.

What is the PDUFA date for SCYNEXIS' ibrexafungerp?

The Prescription Drug User Fee Act (PDUFA) target action date for SCYNEXIS' ibrexafungerp, named Brexafemme, is set for June 1, 2021.

What is Brexafemme and its significance in treating vaginal yeast infections?

Brexafemme is an oral antifungal currently under FDA review for treating vulvovaginal candidiasis, which, if approved, will represent the first novel antifungal class in over 20 years.

Where can I find the posters presented by SCYNEXIS at the ACOG meeting?

The posters from the SCYNEXIS presentations will be available on the company's website and live via the ACOG virtual platform starting April 30, 2021.

What conditions does vulvovaginal candidiasis (VVC) cause?

VVC can cause significant discomfort, including pain, itching, reduced sexual pleasure, and various psychological impacts, affecting many women worldwide.