Artelo Biosciences Inc. (NASDAQ:ARTL), a San Diego, California, and Dublin, Ireland-based clinical-stage biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics targeting the endocannabinoid system, announced on Monday it received a Clinical Trial Authorization (CTA) in the U.K. for its Cancer Appetite Recovery Study (CAReS).
The study will look into ART27.13, a highly potent, peripherally restricted synthetic, dual G protein-coupled receptor agonist believed to target peripheral CB1/CB2 receptors in the endocannabinoid system, which has the potential to increase appetite and food intake. Originally developed by AstraZeneca plc (NASDAQ:AZN), 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.
Understanding Trials In The U.K.
Before a clinical trial is commenced in the U.K. a CTA must be obtained from the country’s Medicines and Healthcare products Regulatory Agency (MHRA).
In order to issue the CTA, the MHRA makes an assessment of the drug candidate’s Investigational Medicinal Product Dossier (IMPD), as well as other key information such as the clinical trial protocol and the investigator brochure before granting a CTA. And ethics committee must also approve the clinical trial before it’s allowed to start.
In this case, the MHRA authorized the initiation of the study: “A Phase 1/2 Trial of Synthetic Cannabinoid ART27.13 in Patients with Cancer Anorexia and Weight Loss.”
Artelo expects the study to initiate enrollment before the end of 2020, and plans to advance ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. The current global market is estimated to be valued in excess of $2 billion per year.
Dr. Andy Yates, a U.K. registered pharmacist who received his Ph.D. in cannabinoid medicinal chemistry, leads the ART 27.13 project in the U.K. Talking about the trial, he told Benzinga, “Receiving our Clinical Trial Authorisation is a significant step towards commencing our CAReS trial in the UK and is the result of many months of hard work by the team and our partner organizations.
“We are excited to be opening up the clinical sites we have already identified in the UK and commence enrolling patients into CAReS by the end of this year. The CTA covers both phases 1 and 2 of the study and allows us to open up sites throughout the UK ensuring that we can hit our recruitment goals of 43 patients with cancer-associated anorexia, whilst being able to operate safely and efficiently in navigating the ongoing Covid-19 situation.”
Lead image by Ilona Szentivanyi. Copyright: Benzinga.