Fed’s Powell opens door to potential rate cuts at Jackson Hole
BOSTON - Seaport Therapeutics has dosed the first patient in its Phase 2b BUOY-1 study testing GlyphAllo (SPT-300) in major depressive disorder (MDD), according to a Thursday statement from parent company PureTech Health plc (NASDAQ:PRTC, LSE:PRTC).
The study will evaluate the oral prodrug of allopregnanolone in approximately 360 patients with MDD, with or without anxious distress. Participants will be randomized to receive either GlyphAllo or placebo once daily over a six-week treatment period.
GlyphAllo utilizes Seaport’s proprietary Glyph platform, which is designed to improve oral bioavailability by enabling drugs to be absorbed through the intestinal lymphatic system. The company reports that allopregnanolone has shown rapid antidepressant and anxiolytic effects in clinical settings but was previously limited by poor oral bioavailability.
"The initiation of BUOY-1 marks a significant milestone for Seaport’s pipeline, bringing us closer to a potential new treatment for major depression," said Daphne Zohar, Co-Founder and Chief Executive Officer at Seaport Therapeutics, in the press release.
The primary endpoint of the study is the change from baseline at six weeks in the Hamilton Depression Rating Scale-17. Following the initial treatment period, eligible patients may enter an open-label extension phase for up to an additional six weeks.
The BUOY-1 study builds on Phase 1 and Phase 2a data. In Phase 1, GlyphAllo demonstrated approximately nine times greater allopregnanolone exposure than previously reported with oral dosing of allopregnanolone. In Phase 2a, the drug significantly reduced stress hormone salivary cortisol compared to placebo in healthy volunteers using the Trier Social Stress Test.
The company stated that GlyphAllo was generally well-tolerated in earlier studies, with mostly mild and transient adverse events.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.