SCYNEXIS to Present Data Supporting the Efficacy of Ibrexafungerp Against Invasive Fungal Infections at IDWeek 2020

Three posters highlight the potential for ibrexafungerp use in treating and preventing serious fungal infections

Jersey City, New Jersey, UNITED STATES


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 ibrexafungerp’s 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:

Title: Efficacy and Safety of Oral Ibrexafungerp in 41 Patients with Refractory Fungal Diseases, Interim Analysis of a Phase 3 Open-label Study (FURI)
Poster #: 1248
Presenter Barbara D. Alexander, M.D., Duke University
Date: October 21, 2020
Highlight: 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 patients 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.
   
Title: Ibrexafungerp Demonstrates Potent and Consistent In Vitro Activity Against >400 Global Candida auris Isolates, Including Isolates with Elevated MIC’s to Echinocandins
Poster #: 733
Author: Nkechi Azie, M.D., SCYNEXIS, Inc.
Date: October 21, 2020
Highlight: 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/mL 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 Model
Poster #: 1251
Presenter: Katyna Borroto-Esoda, SCYNEXIS, Inc.
Date: October 21, 2020
Highlight: A preclinical study demonstrated that a 30 mg/kg B.I.D. dose of 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

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, 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, visit www.scynexis.com.

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