Quolet announces completion of Phase 1 healthy volunteer study evaluating the safety and bioavailability of Cannabidiol in a novel formulation intended for treatment of various neurological and psychiatric diseases

Quolet, a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) (clinicaltrials.gov NCT05032807). CBD is approved for treatment-resistant epilepsy in children, and recent trials suggest that it may be useful for treating other disorders, such as schizophrenia and anxiety. However, oral CBD has relatively poor bioavailability. Researchers at King's College London partnered with the SEEK group to test whether its bioavailability could be improved by administering CBD in a novel patented lipid formulation. This lipid formulation allows high doses of CBD (200mg) to be administered in capsules including only GRAS and/or pharmaceutical approved ingredients.

In a Phase I clinical trial, fourteen healthy volunteers were given a single dose of 1000mg CBD (5 capsules of 200mg each) in two separate visits. In one visit they were given the lipid-CBD, and in the other visit they were given standard CBD-only formulation. For both visits blood levels of CBD and its metabolites were measured at regular intervals, and side effects and blood markers of liver function were monitored.

Lipid-CBD achieved an AUC exposure in the blood nine times higher than the standard CBD-only formulation (611 ng·h/mL vs. 67 ng·h/mL) with statistical significance of p < 0.001. The maximum concentration (Cmax) achieved for the lipid-CBD was 24 times higher than the standard CBD-only formulation (73.0 ng/ml vs. 3.1 ng/ml) also clear statistical significance of p < 0.001. The time course of CBD and the metabolite levels in the blood indicated that there was minimal first-pass liver metabolism of lipid-CBD.

CBD at higher doses has been proven to cause adverse events such as liver toxicity. The blood levels of lipid-CBD and its metabolites has promise in the areas of side effects management and the costs to health economies.

The novel formulation used is naturally derived, UK MHRA registered EU GMP CBD API with a DMF package, manufactured by Brains Bioceutical Corp., which had been purified to such an extent that THC and its metabolites were not detectable in the product or in any of the blood analyses. This feature may be of great interest to researchers and clinicians in jurisdictions where cannabinoid medications are highly regulated.

A parallel study was conducted in rodents by the same KCL team to understand the impact of the lipid formulation on the tissue distribution of CBD. This showed that the lipid formulation was associated with a greater distribution of CBD to the brain, lung, lymphatic and adipose tissue than the regular CBD.

The Centre for Innovative Therapeutics (C-FIT) led the collaboration for KCL. KCL and SEEK Group are now collaborating on the further development of lipid-CBD. Quolet has been appointed as the commercialisation partner for SEEK.

Role of parties:

The human and animal studies were funded by an academic research grant at KCL. BTT Life Sciences, a joint venture between Brains Bioceutical Corp. and Tamar Technologies Ltd, provided the pure Brains Bio CBD API and funded the manufacture of the plain and lipid capsules used in this study.

Quotes:

Professor Philip McGuire, KCL PI (currently at University of Oxford): "CBD is a very promising candidate novel treatment. However, only a small proportion of oral CBD is absorbed. Our results indicate that this issue can be addressed by administering CBD in a lipid formulation. Moreover, this approach appears to increase absorption of CBD via the lymphatic system, which may reduce first pass liver metabolism and the risk of hepatic and gastro-intestinal side effects."

Professor Mitul Mehta, Co-I and Director of C-FIT: "This collaboration demonstrates how our experts can work with SMEs to develop solutions to existing challenges. The potential here is to have a version of CBD which can be easily given in high doses and get to the right organs at the right levels for efficacy. This could be a very important step in developing CBD therapeutics and we are delighted to be here at the beginning."

About Quolet Industries

Quolet Industries is a global biotech startup focused primarily on addressing a unique market need for high-dose cannabidiol (CBD), drug products which minimize liver toxicity. The fast-growing medicinal cannabis industry has been inherently limited to low-dose formulation of CBD. Researching and investigating new treatments for patients that can benefit from CBD.