Aristotle (ARTL) Reports First Patient in CAReS Study with ART27.13 for Treatment of Cancer-Related Anorexia and Weight Loss

Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that target lipid-signaling signaling pathways, including the endocannabinoid system, today announced that the first patient has been dosed in the Company’s Phase 1/2 Cancer Appetite Recovery Study (CAReS) of ART27.13 in Edinburgh, Scotland, UK. ART27.13 is a peripherally selective G-Protein Coupled Receptor (GPCR) full agonist that is being developed as a much-needed therapy for cancer patients suffering from anorexia and weight loss, which affects over 60% of later-stage cancer patients, often impacts quality of life, and can hasten death.

“Commencing enrollment and dosing the first patient in our CAReS study marks another important milestone in advancing ART27.13, which we are developing for patients suffering from the devastating effects of cancer associated anorexia—a multi-billion-dollar addressable market with no pharmacologic standard of care,” stated Andrew Yates, Ph.D., Senior Vice President and Chief Scientific Officer of Artelo. “Notably, we anticipate that we will be able to collect initial safety data from Phase 1 of CAReS before the end of this year, which will determine the most effective and safest dose of ART27.13 to utilize in Phase 2 of the study. ART27.13 has previously demonstrated weight gain in subjects with lower back pain and we look forward to conducting the study in anorexic cancer patients who have suffered significant weight loss.”

"This is an exciting time for a clinical study with Artelo’s lead development drug. So many patients have suffered with substandard options to address the profound weight loss from cancer. With ART27.13 there are grounds for optimism that loss of appetite associated with cancer can be successfully treated," added the lead investigator Barry J.A. Laird, M.D., from the Institute of Genetics and Cancer at the University of Edinburgh, Scotland and enrolling physician of the first participating patient.

About ART27.13ART27.13 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.

About CAReSThe Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in patients with cancer anorexia and weight loss. Anorexia, or the lack or loss of appetite in cancer patients, may result from the cancer and/or its treatment with radiation or chemotherapy. It is common for patients with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. A weight loss of more than 5% can predicted a poor outcome for cancer patients and a lower response to chemotherapy. The Phase 1 portion of the CAReS study is designed to determine the most effective and safest dose of ART27.13 that will be used in the Phase 2 stage. The Phase 2 portion of the CAReS study is designed to determine point estimates of activity of ART27.13 in terms of lean body mass, weight gain, and improvement of anorexia. The study is planned to enroll up to 24 patients in the Phase 1 and 25 participants in the Phase 2. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817)

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