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Artelo Biosciences Initiates the Phase 2a Portion of its CAReS Trial EvaluatingART27.13 for the Treatment of Cancer-Related Anorexia and Weight Loss
SOLANA BEACH, Calif., April 25, 2023 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on
About this update from Artelo Biosciences, Inc.
[{"type":"text","content":"SOLANA BEACH, Calif., April 25, 2023 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced it has initiated the Phase 2a portion of its Cancer Appetite Recovery Study (CAReS), evaluating ART27.13 for the treatment of cancer-related anorexia and weight loss. “To date, ART27.13 has shown favorable tolerability in patients with anorexia and weight loss related to cancer with no significant negative effects attributed to the experimental drug,” said Steven D. Reich, M.D., Chief Medical Officer of Artelo. “Based on the positive safety profile and the response pattern observed in the Phase 1b portion of the trial, a dose of 650 micrograms will be administered to patients in the Phase 2a.” The Phase 2a portion of the CAReS study is a double-blind, placebo-controlled design enrolling 40 patients randomly allocated in a 3:1 ratio to receive ART27.12 or placebo once daily for up to 12 weeks. The study is planned to be conducted at approximately 18 clinical sites in five countries. “We believe ART27.13 can provide a novel way to manage the debilitating effects of anorexia and weight loss in cancer patients who have few, if any, alternatives,” said Gregory D. Gorgas, Artelo’s President and Chief Executive Officer. “By tripling the number of treatment centers and broadening patient eligibility criteria to include concurrent anti-cancer therapies, our goal is to complete Phase 2a patient enrollment by mid-2024.” About ART27.13ART27.13 is a highly potent, peripherally restricted synthetic, dual G-Protein-Coupled Receptor agonist believed to target the cannabinoid receptors CB1 and CB2, which has the potential to increase appetite and food intake. Originally developed by AstraZeneca plc, ART27.13 has been evaluated in five Phase 1 clinical studies including over 200 subjects where it has 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 therap...