Seaport Therapeutics Presents SPT-300 Trial Data at SOBP Annual Meeting

Seaport Therapeutics recently shared promising results from clinical trials of SPT-300 at the Society of Biological Psychiatry Annual Meeting in Austin, Texas. The biopharmaceutical company, noted for its advancements in neuropsychiatry, presented data highlighting SPT-300's potential in treating mood and anxiety disorders, including anxious depression. SPT-300 is an orally administered prodrug of the neurosteroid allopregnanolone, utilizing the Glyph™ platform to enhance bioavailability.

SPT-300 showed remarkable efficacy by achieving nine times greater allopregnanolone exposure in humans compared to previously published data for oral allopregnanolone. This significant finding supports the Glyph platform's ability to improve oral bioavailability, a crucial advancement given allopregnanolone’s naturally low bioavailability when administered orally. This enhanced bioavailability, coupled with its activity and potency, positions SPT-300 as a promising candidate for treating various neuropsychiatric conditions.

The company’s presentations included data from a multi-part Phase 1 trial and a Phase 2a trial using the Trier Social Stress Test (TSST), a recognized model for inducing anxiety in healthy volunteers. These trials assessed safety, tolerability, efficacy, oral bioavailability, and GABAA receptor target engagement. The Phase 1 trial, involving 99 participants, confirmed that SPT-300 was well-tolerated with no severe or serious adverse events. The most common side effect was mild somnolence. The trial's pharmacokinetic data demonstrated that SPT-300 achieved approximately nine times the allopregnanolone exposure compared to oral allopregnanolone reported in published data, validating the Glyph platform’s efficacy.

In the Phase 2a trial, SPT-300 was evaluated in a randomized, placebo-controlled study to measure its impact on stress-induced cortisol levels using the TSST. The results were significant; SPT-300 substantially reduced salivary cortisol levels at all post-TSST timepoints compared to placebo. The reduction in cortisol levels from baseline to peak was highly significant, meeting the study’s primary endpoint. This suggests that SPT-300 effectively regulates the hypothalamic-pituitary-adrenal axis in response to acute stress, indicating its potential in treating stress-related mood and anxiety disorders.

Michael Chen, Ph.D., Co-founder and Chief Scientific Officer of Seaport Therapeutics, underscored the significance of these findings. He stated that the Glyph platform allows SPT-300 to be absorbed through the intestinal lymphatic system, thereby bypassing first-pass metabolism and addressing allopregnanolone’s bioavailability issues while retaining its therapeutic effects. This innovation is crucial for developing effective treatments for depression, anxiety, and other neuropsychiatric conditions.

SPT-300’s development is a step forward in neuropsychiatric drug development, leveraging the Glyph platform’s ability to enhance oral bioavailability and reduce side effects. The platform's potential applications extend to various therapeutic molecules that suffer from low bioavailability due to high first-pass metabolism.

Seaport Therapeutics continues to focus on advancing neuropsychiatric treatments through its innovative Glyph platform, which promises to overcome significant limitations in current drug development. The company’s experienced team, alongside an extensive network of scientists and clinicians, is dedicated to bringing these new treatments to market, addressing unmet needs in neuropsychiatry.

PureTech Health, the parent company of Seaport Therapeutics, supports these developments as part of its broader mission to introduce new classes of medicine for devastating diseases. PureTech’s robust pipeline includes a range of therapeutics developed internally and through its Founded Entities, addressing various clinical needs with innovative solutions.