Artelo Biosciences, Inc. announced that the United Kingdom's Home Office has classified the Company's lead clinical cannabinoid, ART27.13, as “non-controlled” and, therefore, is no longer considered a Schedule 1 controlled substance, which would impose limitations on its production, possession, and supply. The Home Office is the lead government department tasked with major economic, security and safety policies, including drug policy. Artelo is currently enrolling patients in the U.K. in a Phase 1/2 Cancer Appetite Recovery Study to evaluate ART27.13 for the treatment of anorexia in people with cancer.

Cancer anorexia affects up to 60% of patients with advanced-stage cancers and is characterized by loss of appetite, weight loss and tissue wasting, impoverishing quality of life, and often precedes a patient's death. ART27.13 was designed to be peripherally restricted, targeting the cannabinoid receptors in the body's periphery and not the brain, which is a distinguishing feature of the synthetic cannabinoid. Avoiding receptors in the central nervous system has the potential to deliver an effective dose for managing anorexia while minimizing any undesired CNS effects.

ART27.13 is a highly potent, peripherally restricted synthetic, dual GPCR agonist believed to target the cannabinoid receptors CB1/CB2, which has the potential to increase appetite and food intake. Originally developed by AstraZeneca plc, ART27.13 has been in five Phase 1 clinical studies including over 200 subjects where it demonstrated a statistically significant and dose-dependent increase in body weight in healthy subjects. Importantly, the changes in body weight were not associated with fluid retention and the distribution of the drug enables systemic metabolic effects while minimizing central nervous system mediated toxicity.

Artelo is advancing ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss where the current annual global market is estimated to be valued in excess of $2 billion.