Scynexis announces results from Phase 1 SAD/MAD study of SCY-247

SCYNEXIS (SCYX) announced results from a Phase 1 study of SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation. The study evaluated the safety, tolerability and pharmacokinetics of orally administered SCY-247 in healthy participants receiving single ascending doses ranging from 50mg to 900mg and multiple ascending doses ranging from 50mg to 300mg, once a day for 7 days. Each dose level was evaluated in 8 participants, with 6 participants receiving SCY-247 and 2 receiving a matching placebo. A total of 66 participants received SCY-247 and 22 received placebo in the SAD and MAD cohorts. SCY-247 was well tolerated across all evaluated SAD and MAD cohorts. No serious or severe treatment emergent adverse events were reported. The incidence of TEAEs was low and not dose-dependent, with all events being mild or moderate in severity. One participant discontinued the study due to an adverse event that was deemed not to be related to the study drug. The most common adverse events were mild to moderate headache reported in 16.7% of participants receiving SCY-247 and 4.5% of participants receiving placebo, and diarrhea reported in 9% and 9% of participants receiving SCY-247 and placebo respectively. SCY-247 showed generally dose-proportional pharmacokinetics following single and multiple oral doses. The drug was rapidly absorbed and systemic exposure increased with dose. The MAD cohorts of 200mg and 300mg once-daily achieved or exceeded the preliminary target for efficacious exposure, based on pre-clinical models of invasive candidiasis available to date, including models with strains such as Candida auris and echinocandin-resistant Candida glabrata that are resistant to current antifungal treatment options. Overall, the safety, tolerability, and pharmacokinetic profile observed in this study support the continued clinical development of SCY-247. Further details of the results from this study will be presented at an upcoming scientific meeting.