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PRTC Plans Ph2a trials w/ LYT-300 in PPD/Anxiety
PRTC Plans Ph2a trials w/ LYT-300 in PPD/Anxiety.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \n \n 14 February 2023\n \n \n PureTech Health plc\n \n \n \n PureTech to Advance LYT-300 (Oral Allopregnanolone) for the Potential Treatment of Anxiety Disorders and Postpartum Depression\n \n \n \n \n \n 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\n \n \n \n \n \n An open-label, Phase 2a, proof-of-concept clinical trial in women with postpartum depression is expected to initiate in the second half of 2023\n \n \n \n \n \n In a healthy volunteer study, LYT-300 achieved blood levels of allopregnanolone at or above those associated with therapeutic effect in postpartum depression[1] and was generally well-tolerated\n \n \n \n \n \n Allopregnanolone is a natural neurosteroid with proven efficacy that is currently only available as a 60-hour intravenous infusion\n \n \n \n \n \n PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (\"PureTech\" or the \"Company\"), a clinical-stage biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases, today announced that it will advance LYT-300 (oral allopregnanolone) for the potential treatment of anxiety disorders and postpartum depression (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.\n \n \"We believe LYT-300 is the most advanced oral prodrug of natural allopregnanolone and, as such, has the potential to unlock the full therapeutic benefit of allopregnanolone,\" said Julie Krop, M.D., Chief Medical Officer at PureTech. \"Using our proprietary GlyphTM platform, we have made natural allopregnanolone orally bioavailable without permanently chemically modifying the natural neurosteroid. This differentiated approach, which harnesses the validated, fast-acting efficacy of allopregnanolone, may offer an enhanced therapeutic benefit to patients with a wide range of neurological and neuropsychiatric conditions, including anxiety and postpartum depression.\"\n \n \n Social Anxiety Trial Des...