SCYNEXIS reports positive Phase 1 results for SCY‑770 and plans Phase 2 start in Q4 2026
SCYNEXIS Inc. completed a Phase 1 trial of its oral AMPK activator SCY‑770 in 25 healthy volunteers. The drug was well tolerated at doses up to 750 mg daily and received FDA Orphan Drug Designation for autosomal dominant polycystic kidney disease. The company said the data support dose selection for a Phase 2 proof‑of‑concept study slated to begin in the fourth quarter of 2026.
Why it matters
The company expects the Phase 2 trial to provide initial proof‑of‑concept data, which could move SCY‑770 closer to a potential disease‑modifying therapy for ADPKD, a market with only one approved drug. Investors will watch the upcoming trial for any signals of efficacy that could affect SCYNEXIS’s valuation.
Key facts
- 1The Phase 1 study enrolled 25 healthy participants across three cohorts. globenewswire.com
- 2Cohort dosing included a single 500 mg dose, 750 mg once daily, and 500 mg twice daily for seven days. globenewswire.com
- 3SCY‑770 was well tolerated with a favorable safety profile at all tested doses. globenewswire.com
- 4SCY‑770 has received Orphan Drug Designation from the FDA for ADPKD. globenewswire.com
- 5Phase 2 proof‑of‑concept study is on track to start in the fourth quarter of 2026. globenewswire.com
- 6The drug has been evaluated in approximately 300 participants across multiple trials to date. investing.com
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.