PureTech Readies New CBD Capsules for Clinical Trials
PureTech has developed the LYT-310 CBD capsule that it expects to be more effective than the current FDA-approved Epidiolex due to higher bioavailability. The company has put the capsule through preclinical trials and expects to deliver the new capsules to medical researchers to begin clinical trials. The clinical trials should start in the fourth quarter of 2023.
The company saw opportunities to address some features of the current Epidiolex drug. First, Epidiolex requires a large amount of sesame oil for delivery, limiting its use as a treatment for other diseases and broader age groups. Second, Epidiolex is administered in the cheek via a syringe. Third, the syringe only holds 5 ml of CBD solution. Patients needing more CBD must go through multiple administrations of the CBD solution via syringe administration.
LYT-310 does not need sesame seed oil, and a capsule is swallowed, not injected. Patients needing higher doses of CBD will only have to take more capsules. Also noteworthy is that preclinical trials have found that 30 percent of LYT-310 enters the lymphatic system compared to 5 percent for CBD when not modified.
The higher bioavailability is a result of PureTech’s Glyph Technology. This lymphatic-targeting chemistry platform uses the body’s natural lipid absorption and transport process during the oral administration of drugs. CBD is carried in the lymph system.
Daniel Bonner, Ph.D., Vice President at PureTech Health, said, “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.”
Since LYT-310 is administered via the lymphatic system, it is hoped that patients can avoid potential liver and gastrointestinal issues since Epidiolex goes through first-pass metabolism. The FDA has stated the common Epidiolex side effects are diarrhea, drowsiness, decreased appetite, and fatigue.
Developing a more effective CBD therapeutic in a capsule form is exciting news because it makes drug administration cheaper and much more convenient. It also confirms the enormous health value medical experts already see in CBD. Otherwise, biopharmaceutical companies would not invest millions in developing new CBD-based drugs. Should the clinical trials prove that what PureTech says about the biotherapeutic is true, it could lead to producing other CBD-based drugs able to treat various diseases.