PureTech Health plc PRTC PRTC announced the nomination of a new therapeutic candidate, LYT-310, which is an oral 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 Q4 of 2023.
A CBD-based product has received regulatory approval in the United States and Europe to treat seizures resulting from certain rare conditions, but it requires a large volume of a sesame oil-based formulation, which limits its use in broader indications and age groups. PureTech’s LYT-310 is designed to greatly expand the therapeutic application and potential of CBD by:
enabling oral administration in a capsule;
expanding the use of CBD into a broad range of therapeutic areas and patient populations where higher doses are required to achieve a therapeutic effect;
potentially improving safety and reducing gastrointestinal tract side effects that are associated with the currently approved CBD-based treatment by reducing GI and liver exposure;
allowing for a readily scalable, consistent product in a cost-effective manner.
“The nomination of LYT-310 is an exciting expansion of PureTech’s Glyph technology,” stated Daniel Bonner, Ph.D., vice president at PureTech Health. “The data generated to date with LYT-310 further demonstrate our ability to apply the Glyph technology to an array of molecules to enable or greatly enhance oral bioavailability. This approach allows us to unlock the therapeutic potential of a range of molecules with validated efficacy whose development has been limited by first pass metabolism by the liver.”
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, 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.
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