SCYNEXIS Announces Presentations at 2020 IDSOG Virtual Annual Meeting Highlighting Ibrexafungerp’s Potential for the Treatment of Vulvovaginal Candidiasis

Two oral presentations by VVC experts on ibrexafungerp, one in-vitro activity study and one on VANISH-303 study
SCYNEXIS to sponsor symposium: “Current Challenges and Advancements in the Treatment of Vulvovaginal Candidiasis”

JERSEY CITY, N.J., Aug. 13, 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 announced the presentation of two oral abstracts and a sponsored symposium at this year’s Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Virtual Annual Meeting. IDSOG brings together some of the most prominent scientists and clinicians focused on infectious diseases for women, annually. The presentations will highlight clinical results from the Company’s VANISH-303 Phase 3 trial, underscoring the potential of ibrexafungerp as a treatment for vaginal yeast infections, which affect millions of women in the U.S. every year, and include a discussion on the current antifungal diagnostic and treatment landscape.

“We are very excited to share our VANISH-303 data for the first time with the scientific community. The data demonstrated in a large clinical study, that ibrexafungerp was significantly superior when compared to placebo on multiple clinical and microbiological endpoints,” said Dr. Nkechi Azie, Vice President of Clinical Development and Medical Affairs. “For a condition that affects many women but has limited treatment options, all within only one drug class, the market clearly needs a therapeutic alternative. This data, along with the VANISH-306 results, are part of a planned submission of a New Drug Application in the fourth quarter of this year.”

Presentation details:

Title:	In vitro activity of ibrexafungerp in pH 7.0 and pH 4.5 testing environments against 187 fluconazole‐susceptible and ‐resistant candida species from vulvovaginal candidiasis patients.
Presenter:	Jack Sobel, MD, Wayne State University
Type:	Oral abstract
Date:	August 14, 2020
Time:	2:55 p.m. EDT to 3:00 p.m. EDT
Summary:	Dr. Sobel will present data from an in vitro study performed in his laboratory at Wayne State University, demonstrating that acidic pH environments, like the vagina, do not adversely affect the activity and potency of ibrexafungerp unlike fluconazole, which is adversely affected when tested, in the same laboratory, in an in vitro acidic environment.

Title:	Oral ibrexafungerp efficacy and safety in the treatment of vulvovaginal candidiasis: A phase 3, randomized, blinded, study vs. placebo (VANISH‐303)
Presenter:	Jane Schwebke, MD, University of Alabama at Birmingham
Type:	Oral abstract
Date:	August 14, 2020
Time:	3:00 p.m. EDT to 3:05 p.m. EDT
Summary:	Dr. Schwebke, an expert in the field of vaginitis and an ibrexafungerp investigator, will present data from the ibrexafungerp VANISH-303 study highlighting statistically significant superiority in multiple clinical and microbiological endpoints of ibrexafungerp versus placebo and a well-tolerated adverse event profile.

Title:	Current Challenges and Advancements in the Treatment of Vulvovaginal Candidiasis
Presenter:	Jack Sobel, MD, Wayne State University
Type:	Sponsored Symposium
Date:	August 15, 2020
Time:	11:00 a.m. EDT to 11:45 a.m. EDT
Summary:	Dr. Sobel, a world-renowned expert in the field of vaginitis with over 100 publications in vaginal diseases will provide an update of recent advances in the pathogenesis, diagnosis, and treatment of VVC.

All presentations will be available on the SCYNEXIS website in the near future via link.

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational 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 currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC, and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

About SCYNEXIS

SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by developing innovative therapies. The SCYNEXIS team has extensive experience in the life sciences industry, having discovered and developed more than 30 innovative medicines over a broad range of therapeutic areas. The Company's lead product candidate, ibrexafungerp (formerly known as SCY-078), is a novel IV/oral antifungal agent in Phase 3 clinical and preclinical development for the treatment of multiple serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. For more information, visit www.scynexis.com.

Forward Looking Statement

Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding SCYNEXIS remains on track to submit its NDA for the treatment of vaginal yeast infections in the fourth quarter of this year, and that SCYNEXIS anticipates top-line results and the submission of a supplemental NDA for recurrent VVC in the second half of 2021. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS's ability to successfully develop and obtain FDA approval for ibrexafungerp; the expected costs of studies and when they might begin or be concluded; SCYNEXIS’s need for additional capital resources; and SCYNEXIS's reliance on third parties to conduct SCYNEXIS's clinical studies. These and other risks are described more fully in SCYNEXIS's filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Form 10-Q under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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

Source: Scynexis

Released August 13, 2020