PureTech Health announces LYT-300 achieves primary endpoint

PureTech Health announced topline results from its Phase 2a, randomized, placebo-controlled, proof-of-concept trial of LYT-300. The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test, or TSST, a validated clinical model of anxiety in healthy volunteers. Oral administration of LYT-300 achieved the trial’s primary endpoint of a statistically significant reduction versus placebo in the increase from baseline to peak levels of the stress hormone salivary cortisol. The LYT-300 treatment effect size versus placebo was 0.72, as measured by Cohen’s d, which is one of the most common ways to measure effect size. LYT-300 showed a similar effect size to previously observed results for alprazolam, a benzodiazepine drug indicated for treatment of anxiety disorders, when assessed following the TSST procedure. An increase in cortisol levels after the TSST is a physiological response and an objective biomarker of acute stress. Eighty healthy volunteers were randomized and treated with either LYT-300 or placebo in a 1:1 ratio. LYT-300 was well tolerated, with all treatment-related adverse events transient, mild or moderate and consistent with the known pharmacology profile of allopregnanolone. Additional data from the study will be presented in a scientific forum. As part of an overall development strategy in anxiety-related indications, PureTech will be conducting additional studies in 2024. Further guidance will be provided regarding 2024 catalysts associated with the planned studies.