Seaport Therapeutics has started its phase 2b BUOY-1 trial for GlyphAllo, a new oral medication for major depressive disorder (MDD), which can also include anxiety. GlyphAllo is designed to improve upon allopregnanolone, a compound known for its fast-acting effects on depression and anxiety. The trial will test GlyphAllo’s effectiveness, safety, and tolerability in up to 360 adults over six weeks. Participants will be randomly assigned to take either GlyphAllo or a placebo once daily. Some patients may continue taking GlyphAllo in an open-label extension phase for an additional six weeks. The main goal is to measure changes in depression symptoms using the HAM-D-17 scale. Daphne Zohar, CEO of Seaport Therapeutics, said, ‘Starting the BUOY-1 trial is a big step forward in developing a new treatment for depression, which affects nearly 280 million people worldwide—many of whom also struggle with anxiety.’ Antony Loebel, Chief Medical Officer, added, ‘Depression studies are complex, and our team is working to ensure this trial is conducted with the highest standards.’ Earlier phase 1 and 2a trials showed promising results. GlyphAllo provided much higher levels in the body compared to oral allopregnanolone and matched levels seen with IV dosing. Brain activity tests confirmed its effects. In phase 2a, GlyphAllo significantly reduced stress hormone levels in saliva, meeting its main goal with strong statistical significance. The treatment was well-tolerated, with mostly mild and temporary side effects. This trial could confirm GlyphAllo as a new treatment option for depression and anxiety.