Seaport Therapeutics reports positive Phase 1 topline results from driving simulation study
核心洞察
Seaport Therapeutics (搜索) reported positive topline Phase 1 driving simulation results showing evening GlyphAllo (搜索) 375 mg did not impair next-morning driving versus placebo on Day 5.
The key secondary endpoint was also met, with a single 250 mg evening dose showing no next-morning driving impairment versus placebo on Day 2.
GlyphAllo (搜索) was well-tolerated with mostly mild, transient adverse events and no serious adverse events, while zopiclone 7.5 mg confirmed assay sensitivity.
Seaport Therapeutics (搜索) (Nasdaq: SPTX) announced positive topline results from a Phase 1 Driving Simulation Trial of GlyphAllo (搜索) (SPT-300 or Glyph Allopregnanolone), a novel Glyphed oral prodrug of allopregnanolone, in healthy volunteers. The randomized, double-blind, placebo- and active-controlled, three-way crossover trial enrolled 33 healthy volunteers who received GlyphAllo at bedtime and underwent next-morning driving assessments approximately nine hours later using the Cognitive Research Corporation Driving Simulator-MiniSim. The primary endpoint, Standard Deviation of Lateral Position (SDLP), showed that evening dosing of GlyphAllo at 375 mg — the highest dose being investigated in the Phase 2b BUOY-1 trial — did not impair next-morning driving performance compared to placebo on Day 5 following multiple-day dosing. The key secondary endpoint was also met, with a single 250 mg evening dose showing no impairment versus placebo on Day 2.
The trial included zopiclone 7.5 mg as a positive control, which produced statistically significant impairment relative to both GlyphAllo (搜索) and placebo on Day 2 and Day 5, confirming assay sensitivity. GlyphAllo was well-tolerated at all doses, with most adverse events mild and transient and no serious adverse events reported. Seaport plans to submit the results to the U.S. Food and Drug Administration as part of the ongoing development program and to present additional analyses at upcoming scientific meetings.
Seaport is actively enrolling patients in BUOY-1, a two-arm, global, randomized, double-blind, placebo-controlled, potentially registration-enabling Phase 2b trial evaluating the safety and efficacy of GlyphAllo (搜索) in patients with major depressive disorder (搜索), with or without anxious distress. Topline data from BUOY-1 are expected in the first half of 2027.
Source: Seaport Therapeutics Reports Positive Topline Results from Phase 1 Driving Simulation Trial