Seaport Therapeutics (Nasdaq: SPTX) announced positive topline results from a Phase 1 driving simulation trial of GlyphAllo (SPT-300), an oral prodrug of allopregnanolone, in healthy volunteers, according to a company statement.

The trial met its primary endpoint, showing that evening dosing of GlyphAllo at 375 mg did not impair next-morning driving performance compared to placebo on Day 5 following multiple-day dosing. A key secondary endpoint was also met, showing that a single 250 mg dose did not impair next-morning driving performance compared to placebo on Day 2.

The trial included a 7.5 mg dose of zopiclone as a positive control. Zopiclone produced statistically significant impairment relative to both GlyphAllo and placebo on Day 2 and Day 5, confirming the trial's ability to detect an effect on driving performance.

GlyphAllo was well-tolerated at all doses, with most adverse events described as mild and transient. No serious adverse events were reported.

"We are very pleased by the results which showed no next-morning driving impairment at either dose evaluated," said Daphne Zohar, co-founder and chief executive officer of Seaport Therapeutics.

Seaport plans to submit the results to the U.S. Food and Drug Administration as part of its ongoing development program for GlyphAllo. The company is currently enrolling patients in BUOY-1, a Phase 2b trial investigating GlyphAllo in patients with major depressive disorder. Topline data from the BUOY-1 trial is expected in the first half of 2027.