Seaport Therapeutics Reports Positive Phase 1 GlyphAllo Results Using CRC MiniSim

On September 9, Seaport Therapeutics announced positive topline results from its Phase 1 Driving Simulation Trial of GlyphAllo™ (SPT-300), a novel oral prodrug of allopregnanolone in development for major depressive disorder. Seaport reported that the trial met its primary and key secondary endpoints, with no next-morning driving impairment compared with placebo at either dose evaluated.

The trial evaluated next-morning driving performance approximately nine hours after evening administration of GlyphAllo. The 375 mg dose evaluated following multiple-day dosing is also the highest dose currently being investigated in Seaport’s ongoing Phase 2b BUOY-1 trial in major depressive disorder. The study included zopiclone as a positive control, which produced statistically significant impairment and confirmed the trial’s ability to detect an effect on driving performance.

Seaport said the findings provide additional support for the overall profile of GlyphAllo as the program advances and plans to submit the driving simulation results to the U.S. Food and Drug Administration. The company is currently enrolling patients in BUOY-1, with topline results expected in the first half of 2027.

The announcement also identified the Cognitive Research Corporation Driving Simulator-MiniSim as the validated simulator used to assess driving performance in the trial. CRC is proud to have played a role in this work through the CRCDS MiniSim and excited to see the Seaport team reach this important milestone in the GlyphAllo program.

As CRC celebrates its 20^th anniversary, moments like this carry special significance. Since 2006, our team has had the privilege of partnering with sponsors willing to take on difficult questions in neuroscience, and specialized driving research has been part of that focus for more than 18 years.

Seaport’s announcement is an example of what that commitment looks like today. Seeing the CRCDS MiniSim contribute to another sponsor milestone reflects the kind of bold CNS research CRC was built to support. CRC is grateful to have played a role in programs like these and honored to continue alongside sponsors pursuing new possibilities for patients.