PureTech readies oral CBD capsule for clinic to challenge Jazz's Epidiolex

PureTech Health has spied an opportunity to improve on Jazz Pharmaceuticals’ Epidiolex. Armed with its Glyph chemistry platform, the biotech has created an oral capsule formulation of cannabidiol (CBD) that it plans to take into the clinic late next year.

The administration of Epidiolex entails removing up to 5 mL of a CBD solution from a bottle using an oral syringe. The tip of the syringe is then placed against the inside cheek of the patient and used to deliver the solution. Syringes must be prepared and administered multiple times if the patient needs more than 5 mL of the therapy. The use of sesame seed oil in Epidiolex prevents some people from taking the drug.

PureTech sees those attributes as limits on the indications and age groups that Epidiolex can treat. To expand the use of CBD into other patient populations, including adolescents and adults, the biotech has created its own candidate, LYT-310, that is delivered in an oral capsule. 

As well as unlocking populations that require higher doses, PureTech envisages the prospect reducing gastrointestinal and liver exposure to potentially improve on the safety of the incumbent CBD therapy. Other potential benefits include the ability to cost-effectively make a readily scalable, consistent product. 

PureTech has run tests of the oral CBD prodrug in multiple preclinical models, including large animal and non-human primates, and emerged with evidence that LYT-310 achieves a three to fourfold increase in oral exposure versus unmodified CBD in a fasted state. Up to 30% of LYT-310 enters the lymphatics, compared to 5% for unmodified CBD.

If, as PureTech plans, LYT-310 enters phase 1 in the fourth quarter of next year, the prospect will become the second candidate based on the company’s synthetic lymphatic-targeting chemistry platform to reach the clinic. The first candidate, LYT-300, is an oral allopregnanolone formulation that is set to complete phase 1 by the end of the year.