First patients on track for enrollment this year
Targeting multi-billion market with no approved therapies for cancer-related anorexia
LA JOLLA, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that modulate endogenous signaling pathways, including the endocannabinoid system, today announced receipt of the Clinical Trial Authorization (CTA) in the UK for the Company’s Cancer Appetite Recovery Study (CAReS). The Medicines and Healthcare products Regulatory Agency (MHRA) authorized the initiation of the study entitled “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 year end.
“Receiving our Clinical Trial Authorization clears the path to commence our CAReS trial and we are excited about the prospect of enrolling patients this year,” stated Andrew Yates, PhD., Program Leader for ART27.13. “We will now proceed to open up sites throughout the UK with an overall recruitment goal of 43 patients, while maintaining safe and efficient operations during the Covid-19 pandemic.”
Steven D. Reich, M.D., Artelo’s Chief Medical Officer, added, “Cancer-related anorexia is a dramatically underserved market, with no approved therapies.” Cancer-related anorexia affects greater than 60% of advanced stage cancer patients and it is characterized by loss of appetite, weight loss, poor quality of life and often precedes a patient’s death. Reich continued, “The Phase 1/2 CAReS trial is designed to determine the most effective and safest dose and to evaluate activity using criteria such as lean body mass, weight gain, and improvement of anorexia.”
About Artelo Biosciences
Artelo Biosciences, Inc. is a San Diego-based biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate endogenous signaling pathways, including the endocannabinoid system. Artelo is rapidly advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, pain, inflammation, and anxiety. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the company applies leading edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @ArteloBio.
ART27.13 is a highly potent, peripherally restricted synthetic, dual G protein-coupled receptor agonist believed to target peripheral CB1/CB2 receptors, 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 plans to advance 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.
Forward Looking Statements
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