SCY-770 (PXL-770)

June 30, 2026: SCYNEXIS, Inc. (NASDAQ: SCYX) announced initiation of a Phase 1 study of SCY-770, a first-in-class, direct AMP-activated protein kinase (AMPK) activator being developed as a disease-modifying therapy for autosomal dominant polycystic kidney disease (ADPKD). The Phase 1 trial will assess food effect and characterize pharmacokinetics across two dosing regimens to support dose selection for a planned Phase 2 ADPKD proof-of-concept study, which the company said remains on track to initiate in Q4 2026.

The sequential Phase 1 study in healthy participants starts with a single 500 mg dose under fed and fasted conditions; subsequent cohorts will evaluate 750 mg once daily or 500 mg twice daily (or placebo) for seven days. Topline Phase 1 data are expected in Q3 2026.

SCY-770 has received FDA Orphan Drug Designation for ADPKD. The release also notes SCY-770 has been evaluated previously in multiple Phase 1 trials and one Phase 2a trial in nonalcoholic fatty liver disease (NAFLD).