Healthcare
SCYNEXIS Initiates Phase 1 Study of SCY-770, a Novel AMPK Activator for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Dose-optimization data from the Phase 1 study expected Q3 2026 to support Phase 2 proof-of-concept initiation in ADPKD in Q4 2026JERSEY CITY, N.J., June 30, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a clinical-stage biotechnology company advancing novel therapies for severe rare diseases, today announced initiation of a Phase 1 study of SCY-770, a first-in-class, potent and direct AMP-activated protein kinase (AMPK) activator. The study will characterize the food-effect and define
About this update from Scynexis, Inc.
Dose-optimization data from the Phase 1 study expected Q3 2026 to support Phase 2 proof-of-concept initiation in ADPKD in Q4 2026 JERSEY CITY, N.J., June 30, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a clinical-stage biotechnology company advancing novel therapies for severe rare diseases, today announced initiation of a Phase 1 study of SCY-770, a first-in-class, potent and direct AMP-activated protein kinase (AMPK) activator. The study will characterize the food-effect and define the pharmacokinetics of two dosing regimens for SCY-770 to support dose selection for the Phase 2 study in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD), on track for Q4 2026. "Initiating this Phase 1 study of SCY-770 marks an important milestone for SCYNEXIS as we advance a highly differentiated therapy for ADPKD," said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. "SCY-770 is a potent, orally available direct AMPK activator with compelling preclinical data demonstrating inhibition of cyst cell proliferation and reduction of cyst growth in the kidney, along with a well-characterized safety profile in more than 270 clinical trial participants. With limited disease-modifying options available for patients with ADPKD, we are excited to advance this program and remain on track to initiate our Phase 2 proof-of-concept study later this year, a key value inflection point for the company." The Phase 1 study will enroll healthy participants in a sequential design. In the initial cohort, participants will receive a single 500 mg dose of SCY-770 under fed and fasted conditions. Based on these results, subsequent cohorts will evaluate SCY-770 at 750 mg once daily or 500 mg twice daily or placebo, for seven days to inform dose selection for the planned Phase 2 ADPKD study. Topline data are expected in the third quarter of 2026. SCY-770 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ADPKD. About SCY-770 SCY-770, a novel and highly selective, direct Adenosine Monophosphate (AMP)-activated protein kinase (AMPK) activator, is being developed as a disease-modifying therapy for ADPKD, a progressive genetic kidney disorder with significant unmet medical need. AMPK activation suppresses the mTOR and cAMP signaling pathways that drive cyst cell proliferation and fluid secre...