BOSTON - PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) announced today that its Founded Entity, Seaport Therapeutics, presented additional data from a Phase 1 study of SPT-300 at the American College of Neuropsychopharmacology (ACNP) Annual Meeting. The study highlighted multiple well-tolerated doses with pharmacodynamic activity, paving the way for a planned Phase 2b study in major depressive disorder.
The Phase 1 study of SPT-300, an oral prodrug of allopregnanolone, involved 99 healthy volunteers and focused on assessing the compound's oral bioavailability, safety, tolerability, pharmacokinetics, and pharmacodynamics. Allopregnanolone is known for its antidepressant and anxiolytic effects. The study showed that SPT-300 was well-tolerated, with all adverse events being mild or moderate and transient.
New data presented at the ACNP meeting included further safety analyses and pharmacokinetic and pharmacodynamic data. Pharmacodynamic assessments observed changes in EEG beta frequency power and reductions in saccadic eye velocity, which, along with the peak in somnolence, correlated with the pharmacodynamic markers and blood levels of allopregnanolone approximately four hours post-dose.
According to Tony Loebel, M.D., Chief Medical (TASE:PMCN) Officer and President of Clinical Development of Seaport Therapeutics, the Phase 1 results demonstrate that SPT-300 is well-tolerated and exhibits rapidly acting pharmacodynamic activity, reinforcing the potential of SPT-300 as a modulator of GABAA receptors and as a potential antidepressant and anxiolytic agent.
SPT-300 aims to provide the therapeutic benefits of allopregnanolone in an oral form, which could be used on a chronic basis. The Phase 2b placebo-controlled study will further investigate the efficacy of SPT-300 in major depressive disorder with or without anxious distress.
Seaport Therapeutics focuses on advancing novel neuropsychiatric medicines, leveraging its proprietary Glyph technology platform to overcome limitations of clinically validated mechanisms. PureTech Health, a clinical-stage biotherapeutics company, continues to support the development of innovative treatments through its Founded Entities.
This news report is based on a press release statement from PureTech Health plc.
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