PureTech Health announced that it will advance LYT-300 for the potential treatment of anxiety disorders and postpartum depression, or PPD. A placebo-controlled, Phase 2a, proof-of-concept, social anxiety clinical trial in healthy volunteers is expected to begin in the first half of 2023, with results anticipated by the end of 2023. An open-label, Phase 2a, proof-of-concept clinical trial in women with PPD is expected to initiate in the second half of 2023. The placebo-controlled, Phase 2a, proof-of-concept trial will evaluate short-term changes in anxiety-related patient reported outcomes in approximately 50 healthy volunteers. The trial will be conducted using a validated clinical model that simulates social anxiety. The open-label, Phase 2a, proof-of-concept trial will evaluate LYT-300 in a small number of patients with moderate to severe PPD. It is designed to inform dose selection of LYT-300 in this population given the known efficacy of allopregnanolone in this population, and it will evaluate scores on the HAM-D scale as well as other relevant pharmacodynamic markers.
Published first on TheFly
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