Benzinga | Apr 30, 2021 08:08AM EDT

SCYNEXIS Highlights Presentation Of Data At 2021 American College Of Obstetricians And Gynecologists Showing Outcome, Sustained Response Of Investigational Oral Ibrexafungerp In Difficult-To-Treat Patients With Vaginal Yeast Infections

* A single-day dose of oral ibrexafungerp demonstrates positive clinical outcomes in difficult-to-treat vulvovaginal candidiasis (VVC) patient populations: those with non-albicans Candida VVC and/or severe VVC

* Brexafemme, the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vaginal yeast infections, is under regulatory review by the FDA, with a PDUFA target action date set for June 1, 2021

JERSEY CITY, N.J., April 30, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, presented posters on two data sets from the Company's Phase 3 VANISH Program demonstrating the therapeutic potential of ibrexafungerp (Brexafemme) as a treatment for vulvovaginal candidiasis (VVC), also known as vaginal yeast infection, at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting, taking place virtually from April 30 -- May 2, 2021.

Presentation highlights are as follows:

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 A sub-analysis of the VANISH-303 study identified 19 patients in the ibrexafungerp arm (300 mg BID, one-day oral dose) with non-albicans Candida (NAC) VVC. The current treatment recommendation is 7-14 days of topical azoles; fluconazole is not recommended. Treatment with ibrexafungerp resulted in a 42.1% clinical cure rate, defined as complete resolution of all Vaginal Signs and Symptoms (VSS=0) at theSummary: Day-10 test-of-cure visit, and 52.6% symptom resolution at the Day-25 follow-up visit. This analysis shows that clinical outcomes for NAC VVC patients on ibrexafungerp are comparable to all patients in the study. Furthermore, the trend of more patients having positive clinical outcomes and sustained response with ibrexafungerp by Day 25 was observed in all patients and the NAC sub-population. Title: Efficacy and Safety of Oral Ibrexafungerp in the treatment of Vulvovaginal Candidiasis: A Phase 3 Study (VANISH-306)Poster ID957079#:Authors: Dr. Nkechi Azie, Dr. David Angulo, Dr. Ryan Sobel The VANISH-306 study evaluated the safety and efficacy of oral ibrexafungerp as a treatment for patients with VVC (mITT 272 subjects). Severe VVC patients (VSS>7), categorized as complicated patients, accounted for 91.9%% of the patients in the in the study. Current guidelines recommend that patients with severe symptoms receive a longer course of azole therapy. A one-day dose of oral ibrexafungerp demonstrated superiority to placebo, with clinical cureSummary: rate, defined as complete resolution of all Vaginal Signs and Symptoms (VSS=0) at the Day-10 test-of-cure visit, reported as 63.3% in the treatment arm vs. 44.0% in the placebo arm (p=0.007). Additionally, mycological eradication and clinical improvement, defined as VSS equal to 1 or 0, was seen in 58.5% and 72.3% of patients in the treatment arm, respectively, at the Day-10 test-of-cure visit (p<0.001, p<0.01). A one-day oral dose of ibrexafungerp may provide a treatment alternative for patients with VVC in the future, including severe cases where currently available treatments may not be satisfactory.

"Candida albicans has been the prominent species causing vaginal yeast infections, however, we are seeing a notable shift in the etiology candidiasis with non-albicans Candida species gaining prominence. Fluconazole is not recommended for treatment of non-albicans Candida VVC, often because of a high rate of resistance, leaving no oral treatment options for this difficult-to-treat patient population," said Nkechi Azie, M.D., Vice President, Clinical Development and Medical Affairs of SCYNEXIS. "The data sets presented today show ibrexafungerp's potential to treat a broad range of Candida species, including azole-resistant strains, as well as patients with severe VVC."

Dr. Marco Taglietti, President and Chief Executive Officer of SCYNEXIS added, "Last year, an estimated 9.5 million women in the U.S. received prescriptions for vaginal yeast infections, however, about 40% of them required multiple prescriptions, illustrating a growing need for new treatment options. We believe our oral, fungicidal, non-azole candidate, ibrexafungerp, if approved for the treatment of vaginal yeast infections, may provide a significant benefit for clinicians and patients not satisfied with existing azole-based therapies."

Brexafemme, the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vaginal yeast infections, is under regulatory review by the U.S. Food and Drug Administration (FDA) with a PDUFA target action date set for June 1, 2021. The New Drug Application submission to the FDA was supported by positive data from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306) in which oral ibrexafungerp demonstrated statistical superiority with a favorable tolerability profile.

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

The posters will be made be available for 3 months and can be found on the SCYNEXIS website at: https://www.scynexis.com/news-media/events