Seaport Therapeutics says Phase 1 trial shows GlyphAllo 375 mg does not impair next-morning driving vs placebo
SPTX•Next steps
Results will be submitted to the FDA. Additional analyses are planned for future scientific meetings, and BUOY-1 Phase 2b MDD topline data is expected in H1 2027.
Phase 1 driving study results
Seaport Therapeutics reported positive topline Phase 1 driving simulator results for GlyphAllo, its oral prodrug of allopregnanolone.
- Evening dosing at 375 mg showed no next-morning driving impairment versus placebo following multiple-day dosing; a single 250 mg dose also showed no impairment.
- Zopiclone, used as a positive control, caused next-morning impairment, supporting the study’s ability to detect driving effects.
- No serious adverse events were reported; most side effects were mild and transient.
