PureTech Health plc announced the nomination of a new therapeutic candidate, LYT-310, which is an oral cannabidiol (CBD) prodrug and the second therapeutic candidate developed from PureTech's Glyph platform to be advanced toward the clinic. Clinical studies of LYT-310 are expected to begin in Fourth Quarter of 2023. In multiple preclinical models, including large animal and non-human primate, LYT-310 has demonstrated a three to fourfold increase in oral exposure vs.
unmodified CBD in a fasted state. This has the potential to translate into improved safety and reduced side effects. Lymphatic transport has also been confirmed in preclinical models, with up to 30% of LYT-310 entering the lymphatics, compared to 5% for unmodified CBD which further supports the novel Glyph mechanism of enhancing bioavailability.
The first candidate from the Glyph technology platform, LYT-300 (oral allopregnanolone), is currently being evaluated in a multi-part Phase 1 trial designed to demonstrate oral bioavailability, evaluate safety and tolerability across a range of doses, and to inform dose selection moving forward. The first objective was achieved earlier this year, and LYT-300 demonstrated oral bioavailability of allopregnanolone approximately ninefold greater than that of orally administered allopregnanolone, based on previously published data. The Phase 1 clinical trial is expected to be completed by the end of 2022, and based on the data a Phase 1b/2a clinical trial is planned to initiate in 2023.