SCYNEXIS Announces $3 Million National Institutes of Health Grant Has Been Awarded to Case Western Reserve University Researchers to Study Second Generation Fungerp (SCY-247) to Fight Drug-Resistant Fungi

• Researchers to study the potential of SCY-247 to fight Candida auris (C.auris), a multidrug-resistant pathogen named as an “urgent threat” by the Centers for Disease Control (CDC) and included in the “critital priority group” on the World Health Organization (WHO) fungal priority pathogens list (FPPL).
• SCY-247 is a broad-spectrum, oral and IV antifungal under development by SCYNEXIS as a potential systemic therapeutic option for multiple drug-resistant pathogens.

JERSEY CITY, N.J., Nov. 30, 2022 (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 researchers from Case Western Reserve University in Cleveland have been awarded a competitive research grant of more than $3 million by the National Institutes of Health (NIH), to investigate a second generation fungerp (SCY-247) developed by SCYNEXIS as a potential treatment for Candida auris (C.auris), a multidrug-resistant yeast that causes serious and often deadly infections.

The five-year grant from the National Institute of Allergy and Infectious Diseases of NIH will allow the team led by researchers at the Case Western Reserve School of Medicine and University Hospitals Cleveland Medical Center to evaluate this novel antifungal drug developed by SCYNEXIS. The research team will be led by Mahmoud Ghannoum, Ph.D., professor of dermatology and pathology at the School of Medicine and director of the Center for Medical Mycology at University Hospitals Medical Center, Case Western Reserve University, as principal investigator, and Thomas McCormick, Ph.D., an associate professor at the School of Medicine.

“It is thrilling to see the NIH fund this important research to investigate oral and IV SCY-247, one of our patented triterpenoid antifungals, to target drug resistant C. auris, where there is great need due to limited treatment options and the potential to save lives,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We congratulate Dr. Ghannoum on receiving this grant and want to express our gratitude for his ongoing commitment to patients suffering from terrible and deadly fungal infections.”

C. auris has emerged in recent years as a global threat causing serious invasive infections with mortality as high as 60 percent worldwide. The majority of C. auris infections are reportedly resistant to fluconazole (FLU) with variable resistance to other members of the three major classes of clinically available antifungals (azoles, polyenes, echinocandins). Some strains are resistant to all three antifungal classes, thereby limiting treatment options. C. auris has been classified as an “urgent threat” by the Centers for Disease Control (CDC). The World Health Organization (WHO) recently released its first ever fungal priority pathogens list (FPPL), which includes C. auris in the “critical priority group.”

“There is an enormous need to identify and develop new modalities to treat infections caused by the fungal pathogen Candida auris,” Dr. Ghannoum said. “Because C. auris colonizes the skin and acts as a nidus of infection, developing a drug that can concurrently target skin and exhibit systemic efficacy will be highly innovative and desirable. We will investigate whether SCY-247 is a viable option for eradication of C. auris, and whether this compound is effective against known resistant Candida species. The ability of the compound to treat C. auris brain infection also will be assessed.”

About SCY-247

SCY-247 is a second generation fungerp, a triterpenoid class of antifungals, which represents the first new class of antifungal compounds since 2001, and is under development as a potential systemic therapeutic option. The first generation fungerp, ibrexafungerp, formerly known as SCY-078, [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of the novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. While ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients, SCY-247 is in early pre-IND development. SCY-247 has demonstrated broad-spectrum antifungal activity, in vitro and in vivo. SCYNEXIS anticipates that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of SCY-247.

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. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME^® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. SCYNEXIS filed a supplemental New Drug Application (sNDA) to expand BREXAFEMME’s labelling to include the prevention of recurrent vulvovaginal candidiasis, and the FDA assigned a target PDUFA action date of November 30, 2022, for this additional indication. In addition, late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.

CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com

Media Relations
Debbie Etchison
SCYNEXIS
debbie.etchison@scynexis.com