SCYNEXIS Reports Second Quarter 2020 Financial Results and Provides Company Update

In July, SCYNEXIS announced that it had successfully conducted pre-NDA meetings with the FDA regarding ibrexafungerp for the treatment of Vulvovaginal Candidiasis (VVC) more commonly known as vaginal yeast infection. NDA submission for this indication remains on track for Q4 2020.
In July, SCYNEXIS held an investor event with two key opinion leaders (KOLs) to discuss patient perspectives, unmet needs and treatment options in VVC, as well as the related commercial opportunity. This event followed the successful completion of the Phase 3 VANISH program evaluating oral ibrexafungerp for the treatment of VVC.Enrollment is ongoing in the Phase 3 CANDLE study of oral ibrexafungerp for the prevention of recurrent vaginal yeast infections; top-line results and supplemental NDA submission anticipated in the second half of 2021. 
JERSEY CITY, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug resistant infections, today reported financial results for the quarter ended on June 30, 2020 and provided an update on recent clinical and corporate developments.
“We have recently achieved some key milestones with the successful completion of our pivotal VANISH Phase 3 program evaluating oral ibrexafungerp for the treatment of vaginal yeast infections, followed by productive pre-NDA meetings with the FDA,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “In both our VANISH Phase 3 trials, ibrexafungerp treatment resulted in clinically meaningful improvement and statistically significantly greater cure rates when compared to placebo, and we remain on track to submit our NDA for the treatment of vaginal yeast infections in the fourth quarter of this year, setting us up for a potential regulatory approval in mid-2021.  I am extremely proud of our team’s commitment to advancing this program as we transition SCYNEXIS to a fully integrated drug development and commercial company with an initial focus on vaginal yeast infections.”Ibrexafungerp UpdateIbrexafungerp achieved superiority over placebo with a high degree of statistical significance on key study endpoints required for regulatory approval for the treatment of VVC in both VANISH pivotal trials. The two VANISH studies are among the first placebo-controlled trials of an antifungal agent in VVC. The results of these studies provide evidence of ibrexafungerp’s robust and clinically meaningful efficacy with no safety signals identified. Below are the top-line efficacy results of the VANISH pivotal trials: In both VANISH pivotal trials, oral ibrexafungerp was generally well-tolerated. Below is a summary of the higher frequency treatment-emergent adverse events (TEAEs) of the VANISH pivotal trials:Substantial commercial opportunity for oral ibrexafungerp in VVC as a potential novel treatment of choice for the large number of women currently underserved by existing agents. Ibrexafungerp has the potential to address vaginal yeast infections across a broad range of patients and could be an ideal treatment option for the many patients for whom current treatment options are suboptimal.  With over six million women experiencing a yeast infection each year in the U.S., VVC is an under-appreciated, under-reported, and under-served women’s health condition. There are over 15.4 million prescriptions written for VVC in the U.S. annually, all of which belong to a single drug class, the azoles.  There has been no new oral treatment for VVC in over 25 years, and we believe health care providers are eager for a novel alternative to treat their patients.

Ibrexafungerp, if approved, would be the first and only oral, non-azole treatment for vaginal yeast infections. SCYNEXIS believes that ibrexafungerp’s unique combination of features, including its novel class, oral dosing, broad-spectrum, and fungicidal activity in all Candida species (albicans and non-albicans) including fluconazole resistant strains, will differentiate it from competing products.