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LYT-300 Shows Proof of Principle in Clinical Trial
LYT-300 Shows Proof of Principle in Clinical Trial.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \n \n 19 December 2022\n \n \n PureTech Health plc\n \n \n \n PureTech's LYT-300 (Oral Allopregnanolone) Demonstrates Oral Bioavailability, Tolerability and GABAA Receptor Target Engagement in Healthy Volunteers\n \n \n \n Orally administered LYT-300 achieved blood levels of allopregnanolone at or above those associated with therapeutic effect.1 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 Preliminary pharmacodynamic data indicate that oral administration of LYT-300 results in allopregnanolone target engagement with GABAA receptors, which have been shown to regulate mood and other neurological conditions.\n \n \n \n \n \n LYT-300 was generally well-tolerated across the trial with no treatment-related severe or serious adverse events observed.\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 topline results from the completed, multi-part Phase 1 trial of LYT-300 (oral allopregnanolone). \n \n Topline results announced today show that oral administration of LYT-300 achieved blood levels of allopregnanolone at or above those associated with therapeutic benefit1 and resulted in exposure-dependent target engagement with γ-aminobutyric-acid type A (GABAA) receptors. Earlier this year, PureTech announced that LYT-300 also demonstrated oral bioavailability of allopregnanolone approximately ninefold greater than third-party reported data with orally administered allopregnanolone.1 Additional data from the Phase 1 trial will be presented in a scientific forum, and a Phase 1b/2a trial is expected to begin in the first half of 2023.\n \n \"Today's results make us very excited about the potential of LYT-300 to unlock the full therapeutic benefit of allopregnanolone, which to date has been limited to a small subset of patients,\" said Julie Krop, M.D., Chief Medical Officer at PureTech. \"Using our proprietary Glyph platform, orally administered LYT-300 has demonstrated a favorable safety profile at allopregnanolone levels that have been shown to be associated with therapeutic benefit. This, along with evidence of exposure-...