WHO Recognizes New Antifungal Class by Granting ibrexafungerp as International Non-Proprietary Name for SCY-078

SCYNEXIS announced the World Health Organization's (WHO) International Non-proprietary Name (INN) group has assigned the generic name "ibrexafungerp" for its lead candidate SCY-078, the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family. SCYNEXIS is developing ibrexafungerp for the treatment of multiple serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections.

"The WHO's assignment of ibrexafungerp as the generic name for SCY-078 is a significant accomplishment for SCYNEXIS, as this name incorporates a novel stem for our antifungal platform and marks SCY-078 as the first member of a new class of drugs for the treatment of serious fungal infections," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "For nearly two decades, only three drug classes have encompassed all FDA-approved antifungal treatments. Ibrexafungerp has the potential to represent the first new antifungal class approved since 2001, providing unique benefits of critical importance given the rapidly rising rates of antifungal resistance to many standard of care therapies."

The INN system was established to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients in a unique, globally-recognized manner. Obtaining a non-proprietary, or generic, name is a required step in bringing a new drug to market. Generic names of pharmacologically-related substances demonstrate their relationship by using a common "stem," allowing medical practitioners and pharmacists to recognize substances having similar pharmacological activity. This is important for the clear identification, safe prescription and dispensing of medicines to patients. The generic name ibrexafungerp includes a new stem, "-fungerp," which indicates that SCY-078 is unlike any previously-approved drug, and reflects its first-in-class nature.

Ibrexafungerp 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 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 U.S. Food and Drug Administration (FDA) has granted QIDP and Fast Track designations for the formulations of ibrexafungerp for the indications of IC (including candidemia), IA and VVC, and has granted Orphan Drug Designation for the IC and IA indications.

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