Artelo Biosciences Shows Promising Weight Loss Results with ART27.13

Artelo Biosciences has announced promising results from a nonclinical study of its oral, once-daily, peripherally selective dual cannabinoid receptor agonist, ART27.13. The study, conducted in obese mice, demonstrated that ART27.13 achieved weight loss comparable to semaglutide, the active ingredient in Ozempic® and Wegovy®. Moreover, when combined with semaglutide, ART27.13 doubled the weight loss achieved with either agent alone.

In the study, ART27.13, administered as a monotherapy, reduced body weight by approximately 20% in obese mice over a four-week period. This weight loss was comparable to that achieved with semaglutide. When ART27.13 was combined with semaglutide, the obese mice lost approximately 40% of their baseline body weight, bringing them to the body weight of lean, normal-weight animals. The weight loss was predominantly fat loss, with about 80% of the total weight loss attributed to fat reduction in both ART27.13 monotherapy and combination therapy groups, and about 70% in the semaglutide monotherapy group.

The results suggest that ART27.13 may possess the profile of a "metabolic regulator," capable of differentially modifying body weight and other parameters depending on the metabolic phenotype being treated. The findings challenge the long-held assumption in obesity research that cannabinoid receptor antagonists are required for weight loss. Full agonists such as ART27.13, which activate the receptors, have largely been avoided in the pharmaceutical industry.

According to Andrew Yates, Ph.D., Senior Vice President and Chief Scientific Officer of Artelo Biosciences, "The prevailing dogma has been that CB1 antagonism is required for weight loss, so observing semaglutide-like weight loss with a cannabinoid receptor agonist is striking. What makes these data especially compelling is the selectivity. In obese animals, ART27.13 drove substantial fat loss and improved body composition, while in lean animals there was no observed effect on weight, appetite or body composition. That is precisely the profile one would want in an obesity therapeutic."

The study also showed that ART27.13 had no effect on body weight, fat mass, or lean mass in lean mice fed a standard diet. The weight-loss effect of ART27.13 appears to be specific to the obese state. Additionally, the weight loss was maintained as appetite recovered, with food consumption in treated obese animals declining initially and then recovering over the course of the study, while body weight remained at its reduced level.

Metabolic parameters were favorable for ART27.13 monotherapy, with the greatest effects shown in the combination with semaglutide. The findings are consistent with independent, peer-reviewed research showing that both THC and synthetic cannabinoid receptor agonists can reduce body weight and fat in obese animals while having no effect on body weight or metabolic parameters in lean animals.

The results are particularly significant in the context of the global GLP-1 market, which J.P. Morgan has projected could reach $200 billion by 2030. Artelo Biosciences is currently conducting a Phase 2 trial named the Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Interim Phase 2 data revealed that patients who had lost at least 5% of body weight to be included in CAReS and titrated to the highest ART27.13 dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while patients on placebo lost an additional ~5%.

In addition to CAReS, ART27.13 is also being evaluated in a Phase 2 study in people with glaucoma, called the DREAM study, investigating whether oral daily treatment can lower intraocular pressure. The company believes these results warrant further investigation as to the role ART27.13 may play within one of the most important therapeutic categories in medicine.