PureTech Health announced that after positive preclinical studies, the company would pursue clinical trials for LYT-310, which is an oral cannabidiol (CBD) prodrug.
In preclinical models, the company stated that the drug candidate increased bioavailability of CBD fourfold over unmodified CBD. PureTech plans to deliver the treatment orally in a capsule, with clinical trials set to begin in the fourth quarter of 2023.
The company referenced the existing CBD treatment available in US and European Union (EU) markets, in Epidiolex (CBD), also known as Epidyolex in the EU. PureTech noted that this treatment requires a ‘large volume’ of sesame oil-based formulations, adding that this limits its use in broader indications and age groups.
By contrast, PureTech’s LYT-310 drug candidate could be delivered in increased dosages to broaden its therapeutic potential, as well as potentially improving safety and reducing gastrointestinal tract side effects, the company stated.
According to the US Food and Drug Administration (FDA), the common side effects for Epidiolex are somnolence, decreased appetite, diarrhea, and fatigue.
In details provided from preclinical models, PureTech outlined that 30% of LYT-310 enters the lymphatic system, compared to 5% from unmodified CBD, with the company signaling that this highlights the potential for increased bioavailability of its formulation.
Epiodiolex was originally created by GW Pharma, before the company was acquired in 2021 by Jazz Pharmaceuticals for $7.2bn (€6.8bn). At the time, Jazz stated that the reasons behind the acquisition included being able to add Epidiolex to its neuroscience portfolio, citing the drug’s potential to become a ‘near-term blockbuster’.
As a result, any improvement on that product could be financially lucrative to the company involved.
PureTech stated that LYT-310 was created through its Glyph synthetic lymphatic-targeting chemistry platform, which is designed to employ the lymphatic system’s natural lipid absorption and transport process to enable the oral administration of certain therapeutics.
The company’s lead drug candidate is LYT-300 (oral allopregnanolone), which is a potential treatment of neurological and neuropsychological conditions. PureTech plans to begin a Phase Ib/IIa clinical trial in 2023, with readout from a multi-part Phase I clinical trial expects to read out by the end of 2022.
Intravenous delivery of allopregnanolone is approved by the FDA for use as a treatment for postpartum depression.