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SCYNEXIS Initiates Phase 1 Study of SCY-770, a Novel AMPK Activator for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SCYX
  • SCYNEXIS, Inc. initiated a Phase 1 study of SCY-770, a first-in-class direct AMPK activator, on June 30, 2026.
  • The study aims to characterize food effects & define pharmacokinetics for two dosing regimens to support dose selection for a Phase 2 study in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
  • The Phase 2 proof-of-concept study in ADPKD patients is on track to begin in Q4 2026.
  • Topline data from the Phase 1 study is expected in the third quarter of 2026.
  • The Phase 1 design enrolls healthy participants in a sequential format, starting with a single 500 mg dose under fed & fasted conditions.
  • Subsequent cohorts will evaluate SCY-770 at 750 mg once daily or 500 mg twice daily or placebo for seven days.
  • SCY-770 holds Orphan Drug Designation from the U.S. FDA for ADPKD treatment.
  • The therapy targets cyst cell proliferation & cyst growth by suppressing mTOR & cAMP signaling pathways.
  • SCY-770 has a well-characterized safety profile from over 270 clinical trial participants across Phase 1 trials & one Phase 2a trial for NAFLD.
  • SCYNEXIS remains committed to advancing SCY-770 to reduce cyst growth & improve patient quality of life.