Seaport Therapeutics Inc. (NASDAQ: SPTX) reported positive results Wednesday from a phase 1 trial of GlyphAllo, an oral prodrug of allopregnanolone, saying the compound did not impair next-morning driving performance at tested doses.
In the randomized, double-blind study of 33 healthy volunteers, evening dosing of GlyphAllo at 375 mg produced no statistically significant difference in next-morning driving performance compared with placebo on day 5 of multiple-day dosing, the company said. A single 250 mg dose also showed no impairment relative to placebo on day 2, Seaport identified as a key secondary endpoint.
Driving performance was measured approximately nine hours after dosing using the Cognitive Research Corporation Driving Simulator-MiniSim, with the primary metric being the standard deviation of lateral position — a measure of lane weaving used to assess driving impairment.
A 7.5 mg dose of zopiclone was included as a positive control. The active comparator produced statistically significant impairment relative to both GlyphAllo and placebo on day 2 and day 5, Seaport said.
GlyphAllo was well-tolerated across all doses, with most adverse events described as mild and transient. No serious adverse events were reported.
Seaport plans to submit the phase 1 findings to the U.S. Food and Drug Administration as part of its ongoing development program for the compound.
The company is actively enrolling patients in BUOY-1, a phase 2b trial evaluating the safety and efficacy of GlyphAllo in patients with major depressive disorder. Topline data from that study are expected in the first half of 2027.
PureTech Health plc, a London-listed investor and founder entity, has supported Seaport’s development efforts.
