- Seaport Therapeutics has initiated the dosing of the first patient in the Phase 2b BUOY-1 study for GlyphAllo™ (SPT-300) targeting Major Depressive Disorder (MDD), with or without anxious distress.
- GlyphAllo, a novel oral prodrug of allopregnanolone, aims to address limitations of previous treatments and could become a first-in-class option for MDD.
- The study will enroll approximately 360 patients, with results measured by changes in the Hamilton Depression Rating Scale-17 over a six-week treatment period.
Seaport Therapeutics, a clinical-stage biopharmaceutical company, has announced the commencement of its Phase 2b BUOY-1 study, marking a pivotal development in the exploration of GlyphAllo™ (SPT-300) for treating Major Depressive Disorder (MDD), either with or without anxious distress. This effort builds on preceding successful trials and could potentially introduce a first-in-class treatment into the field.
GlyphAllo, a “Glyphed” oral prodrug of allopregnanolone, is formulated to overcome the clinical restrictions of allopregnanolone, an endogenous molecule known for its rapid antidepressant and anxiolytic effects. The BUOY-1 study, a global, double-blind, placebo-controlled clinical trial, is designed to assess the efficacy, safety, and tolerability of GlyphAllo in approximately 360 adult patients. Participants in this study will receive either the prodrug or a placebo over a six-week period, with primary outcomes measured by changes in the Hamilton Depression Rating Scale-17 (HAM-D-17).
The investigational drug, developed through Seaport’s proprietary Glyph™ platform, demonstrates potential for greater oral bioavailability and fewer adverse effects. This technology allows drugs to bypass first-pass liver metabolism by utilizing the lymphatic system, which can enhance drug absorption and minimize typical side effects associated with hepatic metabolism.
PureTech Health plc (PRTC, Financial), which founded Seaport, notes the significance of this trial in potentially providing a novel treatment for the 280 million individuals affected globally by MDD, many of whom also experience anxious distress. The completion of this trial could pave the way for broader application of the Glyph™ platform in neuropsychiatric and other therapeutic areas.
