US clinical-stage biotherapeutics company, Seaport Therapeutics’ investigational allopregnanolone prodrug, SPT-300, has been well tolerated in a Phase I trial.
The company has published data from its double-blind single ascending dose and multiple ascending dose trial (NCT05129865) underlined the safety analyses and pharmacokinetic (PK) and pharmacodynamic (PD) of the oral prodrug in 99 healthy volunteers.
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SPT-300 is being investigated as a potential therapeutic for a range of neurological and neuropsychological conditions, including major depressive disorder (MDD), anxiety, mood disorders and Fragile X-associated tremor/Ataxia syndrome.
In the Phase I data, the company noted increases in electroencephalogram (EEG) beta frequency power and a reduction in saccadic eye velocity both observed approximately four hours following dosing. The most common adverse reaction was somnolence, which researchers say peaked in the first six to eight hours.
The study found that SPT-300 had therapeutically relevant blood levels up to nine times greater than that found in published data on orally administered unmodified allopregnanolone.
Tony Loebel, chief medical officer and president of clinical development at Seaport Therapeutics, said: “Together with previous clinical efficacy data, the further analyses of the Phase I study demonstrate that these doses of SPT-300 are well-tolerated and have rapidly acting pharmacodynamic activity. This reinforces our confidence in SPT-300 as an oral modulator of GABAA receptors and as a potential rapidly acting antidepressant and anxiolytic agent.
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By GlobalData“There is a great need for innovative neuropsychiatric medicines, and an oral form of allopregnanolone has the potential to provide important advantages that we believe will allow for once-daily use on a chronic basis. We look forward to the next phase of our clinical development plan for SPT-300.”
Seaport Therapeutics, a subsidiary of PureTech, presented its findings in the form of a poster at the American College of Neuropsychopharmacology (ACNP) Annual Meeting in Phoenix Arizona. The Phase I data will support a Phase IIb placebo-controlled study of the prodrug in MDD with or without anxious distress.
Elsewhere in the market of MDD, the US Food and Drug Administration (FDA) has approved an investigational new drug (IND) application from Damona Pharmaceuticals, allowing it to begin a Phase I trial of DPX-101. Meanwhile, Arrivo BioVentures’ treatment, SIRT6 activator SP-624, has been found to significantly reduce symptoms of MDD, but only in women.
