PureTech Founded Entity Seaport Therapeutics Reports Positive Topline Results from Phase 1 Driving Simulation Trial of GlyphAllo™ in Healthy Volunteers
Seaport Therapeutics (Nasdaq: SPTX) reported positive topline results from its Phase 1 Driving Simulation Trial of GlyphAllo (SPT-300), with the primary endpoint met — evening dosing at 375 mg, the highest dose in the Phase 2b BUOY-1 trial, did not impair next-morning driving performance versus placebo on Day 5 after multiple-day dosing. The key secondary endpoint was also met, with a single 250 mg evening dose showing no next-morning driving impairment on Day 2. A 7.5 mg zopiclone positive control produced statistically significant impairment, confirming assay sensitivity, and GlyphAllo was well tolerated with no serious adverse events.
Key figures
- Drug Name
- GlyphAllo (SPT-300 or Glyph Allopregnanolone)
- Phase Of Trial
- Phase 1
- Subjects
- 33
- Indication
- major depressive disorder (MDD)
- Doses tested
- ["375 mg","250 mg"]
- Next catalyst
- BUOY-1 Phase 2b topline data expected in the first half of 2027
- Positive control
- zopiclone 7.5 mg produced statistically significant impairment, confirming assay sensitivity
- Primary endpoint
- SDLP (Standard Deviation of Lateral Position) — 375 mg evening dose did not impair next-morning driving vs placebo on Day 5 after multiple-day dosing
- Secondary endpoint
- single 250 mg dose did not impair next-morning driving vs placebo on Day 2
- Serious adverse events
- 0
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