GlobeNewswire Inc | Oct 21, 2020 08:30AM EDT

October 21, 2020

JERSEY CITY, N.J., Oct. 21, 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 that it is presenting three posters on its late-stage, novel broad-spectrum antifungal, ibrexafungerp, at IDWeek 2020. This international forum, hosted annually by leaders in the field of infectious disease, is taking place virtually from October 21 25, 2020.

The poster presentations will highlight clinical and preclinical data supporting ibrexafungerps potential to combat serious and life-threatening fungal infections.

Our fight against infectious diseases is never-ending, with lethal fungal infections lurking in healthcare settings, mostly affecting weak and immunocompromised patients, and claiming more than one million lives in hospitals worldwide each year, said Dr. Nkechi Azie, Vice President of Clinical Development and Medical Affairs at SCYNEXIS. We are committed to advancing ibrexafungerp, representing the first new class of antifungal agents in more than two decades, which possesses broad-spectrum activity including against the two common fungi, Candida and Aspergillus, which are responsible for most of the deadly fungal infections in clinical settings.

SCYNEXIS announced on October 14th that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to obtain approval for a one-day course of oral ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC, commonly known as vaginal yeast infection). The anticipated PDUFA date is in mid-2021.

Presentation details

Efficacy and Safety of Oral Ibrexafungerp in 41 Patients withTitle: Refractory Fungal Diseases, Interim Analysis of a Phase 3 Open-label Study (FURI)Poster #: 1248Presenter: Barbara D. Alexander, M.D., Duke UniversityDate: October 21, 2020 An interim analysis of 41 patients from the Phase 3 clinical study evaluating ibrexafungerp for the treatment of patients with refractory candidiasis or patients who were intolerant to the standard of care (FURI Study) found that 83% of the patientsHighlight: achieved a clinical benefit (including 56% with complete or partial response and 27% with stable disease), compared to 15% with disease progression. One patient was categorized as indeterminate. Ibrexafungerp was well-tolerated with the most common treatment-related adverse events being of gastrointestinal origin. Ibrexafungerp Demonstrates Potent and Consistent In VitroTitle: Activity Against >400 Global Candida auris Isolates, Including Isolates with Elevated MIC?s to EchinocandinsPoster #: 733Author: Nkechi Azie, M.D., SCYNEXIS, Inc.Date: October 21, 2020 A compilation of four independent global in vitro studies testing the activity of ibrexafungerp against a total 445 Candida auris isolates. The ibrexafungerp MIC90 value against the 445 clinical isolates was 1 mg/mL; the modal and MIC50 values were 0.5 mg/mLHighlight: each. Of the 445 isolates, 32 of the C. auris strains had elevated MIC?s to echinocandins. Only 1 of the 32 isolates had elevated MIC?s to ibrexafungerp (> 2 tube dilution above mode). The result highlights ibrexafungerp?s potential to combat the growing urgent global health threat posed by Candida auris. Title: Prevention of Pneumocystis Pneumonia by Ibrexafungerp in a Murine Prophylaxis ModelPoster #: 1251Presenter: Katyna Borroto-Esoda, SCYNEXIS, Inc.Date: October 21, 2020 A preclinical study demonstrated that a 30 mg/kg B.I.D. dose ofHighlight: ibrexafungerp prevented Pneumocystis Pneumonia (PCP) in a murine model, suggesting that it warrants further testing for preventing PCP in immunocompromised patients.

Register to attend IDWeek 2020 via Link

The posters will be made be available for 30 days and can be found on the SCYNEXIS website at: https://www.scynexis.com/news-media/events

AboutSCYNEXIS

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, in late stage development for multiple indications, ranging from vaginal yeast infections (NDA submitted to the FDA) to 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, visitwww.scynexis.com.

CONTACTInvestor RelationsIrina KofflerLifeSci AdvisorsTel: (646) 970-4681ikoffler@lifesciadvisors.com

Media RelationsGloria GasaaturaLifeSci CommunicationsTel: (646) 970-4688ggasaatura@lifescicomms.com