Artelo Biosciences (ARTL) announced the presentation of preliminary data on ART27.13, the Company’s benzimidazole derivative, being studied for cancer-related anorexia. The data was presented by the Principal Investigator, Professor Barry J. A. Laird, Chair of Palliative and Supportive Care, University of Edinburgh and Consultant Physician in Palliative Medicine, Edinburgh Cancer Centre, at the 17th International Conference on Sarcopenia, Cachexia, & Wasting Disorders, held December 6-8, 2024 in Washington D.C. Artelo is evaluating ART27.13 in the Cancer Appetite Recovery Study, a randomized, placebo-controlled Phase 1/2 trial in cancer-related anorexia, which is currently enrolling the Phase 2 of the study. In the Phase 1 of CAReS, ART27.13 was orally administered at 150 to 650 microgram doses in multiple centers throughout the UK and Ireland. The investigational drug was well tolerated with only mild to moderate adverse events observed in a minority of participants. No serious or life-threatening adverse events were recorded. Importantly, at one month of treatment, two-thirds of participants showed evidence the drug was impacting their weight loss with either stabilization or reversal of weight loss associated with their cancer. Open to enrollment in fifteen sites across five countries, the Phase 2 of CAReS is accruing participants at a 650 microgram dosage with planned escalation at 4-week intervals up to a dose of 1300 micrograms per day. In CAReS, all participants receive ART27.13 once-daily for up to 12 weeks and the endpoints include lean body mass, weight gain, quality of life and safety. The Phase 2 portion will also evaluate any impact on activity levels using a monitor attached to the patient’s wrist. The study is expected to complete enrollment during the first half of 2025.
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