SCYNEXIS INC

SCYNEXIS, Inc. is a pharmaceutical company focused on developing treatments for severe rare diseases, with a primary focus on difficult-to-treat and drug-resistant fungal infections. The company develops its proprietary antifungal platform called "fungerps," which are triterpenoids, a novel class of antifungal agents. These agents are glucan synthase inhibitors and have demonstrated activity against a broad range of human fungal pathogens, including Candida, Aspergillus, Pneumocystis, Coccidioides, Histoplasma, Blastomyces genera, and most common mucorales species, including multidrug-resistant strains. Ibrexafungerp, the first fungerp, was approved by the U.S. Food and Drug Administration (FDA) as BREXAFEMME (ibrexafungerp tablets) in 2021 for vulvovaginal candidiasis (VVC) and in 2022 for the reduction in the incidence of recurrent vulvovaginal candidiasis (rVVC). Ibrexafungerp was licensed to GSK in May 2023. A second-generation fungerp, SCY-247, is currently in clinical trials, and other compounds from the fungerp platform are in earlier development stages. The FDA has granted SCY-247 Qualified Infectious Disease Product status and Fast Track designations for its oral formulation. The company recently completed the single and multiple ascending dose portions of a Phase 1 study for oral SCY-247 in 88 healthy subjects. This study evaluated the safety, tolerability, and pharmacokinetics of SCY-247 at single ascending doses from 50mg to 900mg and multiple ascending doses from 50mg to 300mg, once daily for 7 days. A total of 66 participants received SCY-247 and 22 received placebo across these cohorts, and SCY-247 was well tolerated.