Benzinga | Jan 11, 2022 08:34AM EST

Artelo Anticipates Accelerated Clinical Development For ART27.13 Following Its Classification Change In The United Kingdom

Artelo Biosciences, Inc. (NASDAQ:ARTL) 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.

"Collaborating diligently with the Home Office, Artelo was successful in working with governmental regulators to determine that the chemical composition of ART27.13 should not be covered by the Misuse of Drugs Act and, by virtue of the ongoing clinical trials, was also exempted from the Psychoactive Substances Act in the U.K.," stated Andrew Yates, Ph.D., Chief Scientific Officer of Artelo Biosciences. "As a result, Artelo will be able to treat ART27.13 as a normal, non-scheduled Investigational Medicinal Product, which is expected to streamline onboarding of additional clinical sites in the U.K., accelerate enrollment of patients, and enhance the commercial potential of ART27.13," added Dr. Yates.

Artelo is currently enrolling patients in the U.K. in a Phase 1/2 Cancer Appetite Recovery Study (CAReS) 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 (CNS) has the potential to deliver an effective dose for managing anorexia while minimizing any undesired CNS effects.