PureTech Health has identified an opening to create a better alternative to Jazz Pharmaceuticals’ Epidiolex. The biotech company has developed an oral capsule formulation of cannabidiol (CBD) – called LYT-310 – using its Glyph chemistry platform, and it plans to begin clinical trials by the end of next year.
The Glyph chemistry platform is designed to make it more convenient for patients to take certain medicines by mouth. It modifies an existing compound by attaching a molecule of dietary fat to it. This allows the drug to be redirected through the lymphatic system, skipping the liver in the process and moving directly from the gut into the lymphatic vessels that are responsible for processing dietary fats.
To give Epidiolex, a CBD solution is drawn from a bottle and dispensed into an oral syringe in doses of up to 5 milliliters. The solution is administered by pressing the pointed end of the syringe against the patient’s inner cheek. Patients who require more than 5 milliliters of the therapy will require multiple syringe preparations and dosages.
Because it contains sesame seed oil, Epidiolex isn’t suitable for everyone. PureTech is of the view that these characteristics restrict which conditions and ages Epidiolex can treat. This is among the primary reasons why the biotech has developed its own candidate to increase access to the compound for a wider range of patients, including older kids and adults.
PureTech foresees the possibility of lowering gastrointestinal and liver exposure, which could enhance the safety of the current CBD therapy and make it accessible to populations that need higher doses. One more potential advantage is the ability to produce a product that is consistent and easily scalable, while minimizing production costs.
“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.”
The company has conducted studies on the oral CBD drug in a variety of preclinical models, most of which included large animals and non-human mammals. The results of these studies have provided evidence that LYT-310 achieves a three to four times increase in oral exposure in comparison to unmodified CBD when the subject is in a fasted state. As much as 30% of LYT-310 makes it into the lymphatics, while only 5% of unmodified CBD does.
If all goes according to plan, PureTech will begin phase 1 testing of LYT-310 in the fourth quarter of 2023. The new drug will be the second based on the company’s lymphatic-targeting chemistry platform to officially enter the clinic.
The first drug, LYT-300, is presently undergoing evaluation in a multi-stage Phase 1 trial. The goals of the trial are to prove the drug’s oral bioavailability, assess its safety and suitability across multiple doses, and help with future dosing decisions.
