Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups.
In a press release, the Massachusetts-based company said this could include both rare and more common forms of epilepsy and other central nervous system disorders.
The CBD candidate capsule, LYT-310, was developed using PureTech’s proprietary Glyph platform and is expected to advance into clinical studies in the latter part of 2023.
In preclinical studies, the CBD drug candidate was shown to have a three- to four-fold increase in oral exposure compared with unmodified CBD in a fasted state. PureTech said this could potentially mean improved safety and reduced side effects.
LYT-310 is PureTech’s second oral CBD candidate in its pipeline.
The CBD prodrug will be going up against Jazz Pharma’s Epidiolex, the first FDA approved CBD drug formulation. Approved in 2018, Epidiolex is a CBD oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, rare and severe forms of epilepsy, in patients two years of age and older. In 2020, Epidiolex was approved for an additional indication in treating seizures associated with tuberous sclerosis complex (TSC). Jazz bought out Epidiolex developer GW Pharmaceuticals for the drug in a whopping $7.2 billion deal in 2021.
Related: Jazz Pharma Announces $100 Million “Green” Manufacturing Plant for Cannabis-Based Medicines
Epidiolex contains sesame seed oil, restricting its use for some individuals. PureTech’s CBD capsule overcomes this issue as its formulated as an oral capsule. The capsule formulation also allows for achieving higher doses in some patient populations, such as adolescents and adults, to have a greater therapeutic effect.
Other benefits of an oral capsule form of CBD include cheaper pricing and the potential for better safety and reduced GI side effects through reduced exposure to the GI tract and liver, a problem associated with Epidiolex.
“The nomination of LYT-310 is an exciting expansion of PureTech’s Glyph technology,” said Daniel Bonner, PhD, 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,” explained Bonner.
PureTech’s Glyph system is a synthetic lymphatic-targeting chemistry platform designed to leverage the lymphatic system’s natural lipid absorption and transport process to allow for the oral administration of certain therapeutics. Glyph creates a novel prodrug by reversibly linking a drug to a dietary fat molecule, which allows for the drug to be taken up into the systemic circulation by bypassing the liver and instead, being routed directly from the gut (that processes the dietary fat of the prodrug) to lymphatic vessels.
PureTech’s other CBD pill candidate, LYT-300 (oral allopregnanolone), is currently being evaluated in a multi-part Phase I trial evaluating its oral bioavailability, safety and tolerability and optimal dosing. The first objective was achieved earlier this year, with LYT-300 demonstrating oral bioavailability of allopregnanolone that was around nine-fold higher than that of orally administered allopregnanolone. The Phase I trial is expected to be complete by the end of the year with plans to begin a Phase Ib/IIa clinical trial in 2023 based on the Phase I data.
Big pharma continues to eye the medicinal CBD market as it’s currently wide open with high anticipation of growth with new products. Last year, Pfizer struck a $6.7 billion deal with Arena Pharmaceuticals for its cannabinoid-type therapeutic portfolio.
Meanwhile, net product sales of Epidiolex grew by 22 percent to $196.2 million in Q3 of 2022 compared to the same quarter last year.
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