Seaport Therapeutics Advances Promising Depression Treatment
Seaport Therapeutics has officially dosed the first patient in its eagerly anticipated phase 2b BUOY-1 trial of GlyphAllo, a novel oral prodrug of allopregnanolone designed to tackle major depressive disorder (MDD), with or without anxious distress.
This landmark study represents a pivotal moment in the company’s journey toward offering a new class of treatment for depression – one that not only targets core depressive symptoms but also addresses the commonly co-occurring issue of anxiety.
A Next-Generation Candidate for Depression and Anxiety
Allopregnanolone, a naturally occurring neurosteroid, has long been recognised for its rapid-acting antidepressant and anxiolytic properties.
However, delivering it effectively has posed significant clinical challenges, particularly in oral formulations. GlyphAllo was developed specifically to overcome those limitations, and the BUOY-1 trial builds on compelling evidence from earlier clinical studies.
Phase 1 results demonstrated that GlyphAllo achieved nine times greater exposure than standard oral allopregnanolone and matched concentrations seen with intravenous administration.
Additionally, EEG and eye movement assessments confirmed dose-dependent activity in the brain, suggesting robust pharmacodynamic effects. The subsequent phase 2a trial further reinforced its promise, with GlyphAllo meeting its primary endpoint by significantly reducing salivary cortisol levels in a validated stress model (p=0.0001).
Importantly, the compound was well-tolerated with predominantly mild and transient side effects.
Inside the BUOY-1 Trial
The phase 2b BUOY-1 trial will enrol up to 360 adult participants, who will be randomised to receive either GlyphAllo or placebo once daily over six weeks.
Participants who complete the core phase may enter a six-week open-label extension, allowing them to continue on GlyphAllo. The study’s primary endpoint is the change from baseline on the HAM-D-17 depression rating scale, a gold standard for measuring symptom severity in MDD.
With MDD affecting approximately 280 million people worldwide – and an estimated 60% of those individuals also suffering from anxious distress – BUOY-1 represents a vital step in addressing one of the most urgent unmet needs in mental healthcare.
Expert-Driven Execution
Seaport’s leadership has voiced strong confidence in the trial’s scientific and therapeutic potential. The company’s CEO stated that the initiation of BUOY-1 marks a significant milestone for their pipeline and brings them closer to a new potential treatment for major depression.
Meanwhile, the Chief Medical Officer acknowledged the inherent complexities of CNS clinical trials and emphasised the depth of expertise being applied to ensure rigorous study design and execution.
Conclusion: A Step Forward in Mental Health Innovation
With the launch of BUOY-1, Seaport Therapeutics is not only advancing its clinical pipeline but also contributing to a broader shift in how mental health conditions like MDD are approached – through faster, more targeted, and better-tolerated interventions.
If successful, GlyphAllo could become a first-in-class oral therapy that provides a new lifeline for patients who suffer from depression and anxiety.
One thing is certain, the global mental health community will be watching closely as this promising compound moves through its next phase of development.
News Credits: Seaport Therapeutics begins phase 2b trial of GlyphAllo for major depression
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