Artelo Biosciences announces interim Phase 2 CAReS results

Artelo Biosciences (ARTL) announced interim results from its Phase 2 Cancer Appetite Recovery Study trial with ART27.13, the Company’s peripherally acting cannabinoid receptor agonist for the treatment of cancer anorexia-cachexia syndrome. Affecting up to 80% of people living with cancer, CACS is marked by loss of appetite, weight loss, and breakdown of muscle and fat. This leading cause of death in cancer patients has no FDA-approved treatment. The CAReS interim data comparing ART27.13 to placebo supports acceleration of the Company’s partnering initiatives with its lead clinical program. Patients escalated to the 1300 microgram dose achieved a +6.38% mean weight gain after 12 weeks, compared to a -5.42% average loss on placebo. The maximum gain observed was +18.5% on ART27.13 versus only +0.4% on placebo. At one month, patients treated with ART27.13 experienced a +4.23% increase in lean body mass, while placebo patients lost -3.15%. Patients receiving treatment showed improvements in activity scores and in moderate and vigorous activity, the latter being an endpoint that may be required by regulators for drug approval. ART27.13 was well tolerated. The most common adverse events were mild or moderate. No new safety signals were observed and interim safety results were consistent with Phase 1 of CAReS. The Phase 2 CAReS study is evaluating ART27.13 as a once-daily oral treatment aimed at improving weight, appetite, activity, and quality of life in cancer patients who had lost a minimum of 5% of their body weight in the prior six months. Effectiveness was measured by changes in lean body mass, weight, appetite, and activity over 12 weeks and at a 30-day follow-up. Activity and quality of life were assessed using wearable monitors and standardized questionnaires, while safety was closely tracked through adverse event reporting, laboratory tests, vital signs, visual analogue scales, and ECGs. In the interim analysis, 18 evaluable patients-primarily with lung and gastrointestinal cancers not receiving cyclic chemotherapy-were included. After 12 weeks of treatment in patients who titrated to the top dose evaluated of 1300 micrograms, ART27.13 demonstrated compelling increases in mean body weight of 6.38% compared to patients on placebo who lost -5.42%. The maximum weight gain in the ART27.13 group reached 18.5%, versus only 0.4% in placebo. The maximum weight loss in the placebo arm was -17.4%, compared to just -3.0% in the ART27.13 group. Additional benefits were seen in lean body mass, with a +4.23% increase in the treatment group versus a -3.15% loss in placebo at one month, as well as qualitative improvements in total and weekly activity scores. Safety results were consistent with prior findings. Among the 32 participants enrolled in the CAReS Phase 2 trial to date, 7 patients experienced adverse events that may be related to ART27.13. All were mild or moderate, with the exception of a single case of severe malaise, and no drug-related serious adverse events were reported. These data are aligned with safety outcomes observed in Phase 1 of CAReS, supporting ART27.13’s overall favorable tolerability and acceptable safety profile.