Artelo Biosciences Presents Phase 1 Data on ART27.13 for Cancer-Related Anorexia

Artelo Biosciences, a pharmaceutical company specializing in the development of treatments for cancer, announced promising preliminary results from the Phase 1 segment of the Cancer Appetite Recovery Study (CAReS) involving their drug candidate ART27.13. ART27.13 is a benzimidazole derivative being evaluated for its potential in treating cancer-related anorexia. The data was presented at the International Conference on Sarcopenia, Cachexia, & Wasting Disorders in Washington D.C. by Professor Barry J. A. Laird of the University of Edinburgh.

The CAReS trial is a randomized, placebo-controlled study aiming to assess the safety and efficacy of ART27.13. During Phase 1 of the trial, ART27.13 was administered orally in doses ranging from 150 to 650 micrograms across multiple sites in the UK and Ireland. The drug demonstrated a favorable safety profile, with only mild to moderate adverse events in a minority of participants and no serious or life-threatening side effects. Importantly, after one month of treatment, two-thirds of the participants experienced stabilization or reversal of weight loss associated with their cancer.

Professor Laird expressed optimism about the results, noting the lack of approved therapies for cancer-related anorexia in the UK, US, or Europe. He highlighted the effectiveness of ART27.13 at low doses and its tolerability in patients with advanced cancer. This has led to the highest dose from Phase 1 being chosen as the starting dose for the ongoing Phase 2 of the trial.

Phase 2 of the CAReS study is currently enrolling participants across fifteen sites in five countries. Participants receive a daily dose of 650 micrograms of ART27.13, with planned dose escalation up to 1300 micrograms over 4-week intervals. This phase aims to evaluate the drug's impact on lean body mass, weight gain, quality of life, and safety over a 12-week period. Additionally, the study will monitor participants' activity levels using a wrist-worn device. The enrollment for Phase 2 is expected to be completed in the first half of 2025.

Dr. Steven D. Reich, Artelo Biosciences' Chief Medical Officer, commented on the significant potential of ART27.13 in treating anorexia and weight loss in cancer patients. He referenced preclinical research indicating the drug's protective effects against muscle degeneration in cancer cachexia. The use of a wearable monitor in the trial may provide further insights into the drug's impact on patient activity levels.

ART27.13, originally developed by AstraZeneca plc, is an orally administered drug aimed at improving body weight, appetite, muscle health, and quality of life in cancer patients. It is a potent CB1 and CB2 receptor agonist that acts peripherally, minimizing central nervous system-related toxicity. In previous clinical studies, the drug showed a significant, dose-dependent increase in body weight in patients with back pain. The Phase 1 study in cancer patients confirmed its safety, and it is now being tested in Phase 2 for its efficacy in treating cancer-related anorexia and weight loss. Currently, there are no FDA or EMA-approved treatments for cancer anorexia cachexia syndrome.

Artelo Biosciences is committed to developing therapeutics that modulate lipid-signaling pathways to address unmet medical needs in various diseases, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. The company leverages scientific, regulatory, and commercial expertise to advance its portfolio of product candidates.