Seaport Therapeutics’ IPO supports a clinical pipeline built around its Glyph platform, which is designed to help certain oral drugs bypass liver metabolism.
Seaport Therapeutics entered the public market this spring, raising $260 million in gross proceeds through an upsized IPO to support its pipeline of neuropsychiatric medicines.
The Boston-based clinical-stage biotech’s IPO shares began trading on the Nasdaq Global Select Market on May 1 under the ticker symbol “SPTX.”
The IPO, along with cash already on hand, is expected to fund operations into 2029.
The neuropsychiatry space already has some approved treatments. Options for adults with major depressive disorder (MDD) include Axsome Therapeutics’ Auvelity, AbbVie’s Vraylar as an add-on to antidepressants and Johnson & Johnson’s Spravato for treatment-resistant depression.
The FDA also recently made headlines for its actions around psychedelic-related therapies. In April, the agency issued priority vouchers to companies studying psilocybin for depression and methylone for PTSD. It also stressed that these therapies must be backed by strong clinical evidence.
Bypassing the Liver via the Lymphatic System
Seaport’s work is built around its Glyph platform, a drug-delivery approach designed to improve how certain oral medicines are absorbed in the body.
Many oral drugs pass through the liver before enough medicine reaches the bloodstream. This process, known as first-pass metabolism, can reduce the amount of active drug available in the body and may contribute to liver-related side effects.
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Glyph is designed to take a different route. The platform is meant to help certain medicines behave more like dietary fats during absorption, allowing them to move through the intestinal lymphatic system rather than going first through the liver. Seaport is using this approach to revisit medicines or mechanisms that have shown clinical promise but have been limited by absorption, dosing or tolerability challenges.
The company’s most advanced candidate is GlyphAllo (SPT-300 or Glyph Allopregnanolone), an oral prodrug of allopregnanolone being developed for MDD, including MDD with anxious distress. Allopregnanolone is a naturally occurring neurosteroid that has been clinically validated in postpartum depression, but its broader use has been limited in part by oral bioavailability challenges.
A Pipeline Built Around Depression and Anxiety
Seaport is currently enrolling patients in BUOY-1, a global Phase IIb trial evaluating GlyphAllo in adults with MDD, with or without anxious distress. The trial is expected to enroll about 360 patients, and topline data are expected in the first half of 2027.
The company has also dosed the first participant in a Phase I driving simulation trial of GlyphAllo. That study is evaluating whether evening dosing affects next-morning driving performance in healthy volunteers, with data expected in the second half of 2026.
Seaport’s second clinical program is GlyphAgo (SPT-320 or Glyph Agomelatine), an oral prodrug of agomelatine being developed for generalized anxiety disorder (GAD), a condition marked by persistent, excessive worry that can disrupt daily life. Agomelatine is already approved for GAD in Australia and for MDD in Australia and the European Union, but it is not approved in the US. Its use has also been limited by liver-related monitoring requirements.
In June, Seaport reported new Phase I data showing that seven days of repeat dosing with GlyphAgo achieved agomelatine exposure levels that the company says may help avoid liver enzyme elevations and reduce or potentially eliminate the need for liver function testing. Across the evaluated dose levels, no serious, severe or liver-related adverse events were observed.
These findings support Seaport’s plan to move GlyphAgo into two Phase II trials. A Phase IIa study in patients with GAD and sleep disturbance is expected to begin in the second half of 2026, with topline data expected in early 2028. A Phase IIb trial evaluating safety and efficacy in GAD is expected to begin in the first half of 2027, with topline data expected by the end of 2028.
Seaport is also advancing Glyph2BLSD (SPT-348 or Glyph 2-bromo-LSD), a preclinical program based on a non-hallucinogenic LSD analog. The company is studying it for depressive disorders, including treatment-resistant depression, as well as post-traumatic stress disorder and certain headache disorders.
First-in-human-enabling studies for Glyph2BLSD are expected to be completed by the end of 2027, giving Seaport several clinical and preclinical milestones to pursue following its public market debut.
More large drugmakers are investing in neuropsychiatry. In June, Otsuka completed its acquisition of Transcend Therapeutics, adding TSND-201 (methylone), a Phase III rapid-acting treatment candidate for PTSD with FDA Breakthrough Therapy designation.
FAQs
What is a prodrug?
A prodrug is a medicine designed to change into its active form after it enters the body. This approach can sometimes help improve how a drug is absorbed or tolerated.
What does “topline data” mean in a clinical trial?
Topline data are the first high-level results from a clinical trial. They usually show whether a study met its main goals before the full results are published or presented.
Why is Seaport running a driving simulation trial?
Some medicines that affect the brain may cause sleepiness or affect alertness. A driving simulation trial helps evaluate whether a drug could affect next-morning driving performance.
Is Seaport Therapeutics’ pipeline FDA-approved?
No. Seaport’s candidates are still investigational and are being tested in clinical or preclinical studies.
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