The World Health Organization Recognizes New Antifungal Class by Granting "ibrexafungerp" to SCYNEXIS as the International Non-Proprietary Name for SCY-078
New WHO INN stem "-fungerp" signifies a novel class of antifungals
Novel generic name highlights the unique attributes of SCY-078 and its potential to address significant unmet needs across multiple indications
JERSEY CITY, N.J., July 18, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced that the World Health Organization's (WHO) International Non-proprietary Name (INN) group has assigned the generic name "ibrexafungerp" [pronounced eye-BREX-ah-FUN-jerp] 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.
"We are progressing preclinical screening of additional members of the 'fungerp' family as we seek to expand our portfolio of assets and maximize the potential clinical utility of this new family of compounds," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "We also continue to progress the development of our lead compound, ibrexafungerp, in multiple serious indications, building on the recent positive results of oral ibrexafungerp in our Phase 2b DOVE study for VVC."
About Ibrexafungerp (formerly SCY-078)
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 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.
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, discovering and developing more than 30 innovative medicines over a broad range of therapeutic areas. SCYNEXIS's lead product candidate, ibrexafungerp (formerly SCY-078), is a novel IV/oral antifungal agent in Phase 2 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. 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; 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 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.
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Released July 18, 2018