SCYNEXIS Announces Positive Results from a Phase 1, Single Ascending Dose and Multiple Ascending Dose Study of its Second-Generation Fungerp (SCY-247)

Core Insights - SCYNEXIS, Inc. announced positive results from a Phase 1 study of SCY-247, a second-generation triterpenoid antifungal aimed at treating and preventing invasive fungal infections, showing potential for both oral and IV formulations [1][2] Phase 1 Study Overview - The Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SCY-247 in healthy participants, with single ascending doses (SAD) ranging from 50mg to 900mg and multiple ascending doses (MAD) from 50mg to 300mg, administered once daily for 7 days [3] - A total of 66 participants received SCY-247 and 22 received a placebo across the SAD and MAD cohorts [3] Phase 1 Study Results - SCY-247 was well tolerated, with no serious or severe treatment-emergent adverse events (TEAEs) reported, and the incidence of TEAEs was low and not dose-dependent [4] - The most common adverse events included mild to moderate headache in 16.7% of SCY-247 participants and diarrhea in 9% of both SCY-247 and placebo participants [4] Pharmacokinetics and Efficacy - SCY-247 demonstrated generally dose-proportional pharmacokinetics, with rapid absorption (Tmax ranging from 3 to 7 hours) and increased systemic exposure (Cmax and AUC) with dose [5] - The MAD cohorts of 200mg and 300mg achieved or exceeded the preliminary target for efficacious exposure based on pre-clinical models, including resistant strains like Candida auris and echinocandin-resistant Candida glabrata [5] Company Background - SCYNEXIS is a biotechnology company focused on developing innovative antifungal medicines to address drug-resistant infections, with its first product, Ibrexafungerp, already approved for vulvovaginal candidiasis [6][8] - The company is advancing its proprietary antifungal platform "fungerps" and has ongoing late-stage clinical investigations for Ibrexafungerp in life-threatening invasive fungal infections [6]