First Affected person Dosed in Part 2b Examine of GlyphAllo for Sufferers With Main Depressive Dysfunction, With or With out Anxious Stress

Seaport Therapeutics right this moment introduced that the primary affected person has been dosed within the section 2b BUOY-1 examine of GlyphAllo (Glyph Allopregnanolone, or SPT-300) in main depressive dysfunction (MDD) with or with out anxious misery. If profitable, GlyphAllo could possibly be a first-in-class remedy for sufferers with MDD, with or with out anxious misery.¹

GlyphAllo is a novel, “glyphed” oral prodrug of allopregnanolone. Allopregnanolone has been clinically validated in third-party trials as a quickly appearing antidepressant with anxiolytic results, however its scope of scientific use was beforehand constrained by limitations that the Glyph platform is particularly designed to resolve.

Within the international, randomized, double-blind, placebo-controlled BUOY-1 examine, investigators will consider the efficacy, security, and tolerability of GlyphAllo in adults with MDD, with or with out anxious misery. The examine is anticipated to enroll as much as roughly 360 members, randomly assigned 1:1 to obtain both GlyphAllo or placebo once-daily over a 6-week remedy interval. The first endpoint is change from baseline at 6 weeks within the Hamilton Melancholy Ranking Scale-17 (HAM-D-17). Following the preliminary remedy interval, eligible members might enter an open-label extension section, throughout which all members will obtain GlyphAllo for as much as an extra 6 weeks.

“CNS scientific trials are inherently complicated, and we’re making use of our staff’s in depth experience to implement a high-quality examine,” stated Antony Loebel, MD, chief medical officer and president of Medical Improvement at Seaport Therapeutics. “We’re assured that our rigorous scientific trial execution, together with an emphasis on the standard of affected person enrollment, will construct on a confirmed mechanism and established scientific efficacy, to extend our probability of success in growing an efficient remedy for sufferers with despair.”¹

This examine builds on a basis of optimistic scientific knowledge from section 1 and section 2a research of GlyphAllo in wholesome volunteers. In section 1, GlyphAllo demonstrated roughly 9 instances better allopregnanolone publicity than oral dosing of allopregnanolone and reached comparable exposures to the efficacious doses of intravenous-infused allopregnanolone. Each EEG beta frequency energy and discount in saccadic eye velocity confirmed that GlyphAllo engaged with its goal in a dose-dependent method. Investigators have thus decided that the general security knowledge, pharmacokinetics, and pharmacodynamic findings help 6-week dosing of GlyphAllo in BUOY-1.

In a section 2a proof-of-concept examine in wholesome volunteers utilizing the Trier Social Stress Take a look at (TSST), GlyphAllo considerably lowered the stress hormone salivary cortisol in any respect post-TSST timepoints in contrast with placebo. GlyphAllo met the first endpoint with a P-value of 0.0001, demonstrating that GlyphAllo regulates hypothalamic-pituitary-adrenal axis reactivity to acute stress. GlyphAllo was typically well-tolerated. Hostile occasions had been largely gentle and transient.

“The initiation of BUOY-1 marks a big milestone for Seaport’s pipeline, bringing us nearer to a possible new remedy for main despair, which impacts round 280 million folks globally—practically 60% of whom additionally expertise anxious misery,” stated Daphne Zohar, cofounder and chief govt officer at Seaport Therapeutics. “This is a crucial step on our journey to ship new remedies for sufferers residing with despair, nervousness, and different neuropsychiatric circumstances.”¹

Reference

1. Seaport Therapeutics declares first affected person dosed in section 2b BUOY-1 examine of GlyphAllo (SPT-300) in main depressive dysfunction (MDD), with or with out anxious misery. Information launch. July 17, 2025. Accessed July 17, 2025. https://seaporttx.com/press-release/seaport-therapeutics-announces-first-patient-dosed-in-phase-2b-buoy-1-study-of-glyphallotm-spt-300-in-major-depressive-disorder-mdd-with-or-without-anxious-distress/