Artelo Biosciences (NASDAQ: ARTL) announced positive interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS), evaluating ART27.13 in patients suffering from cancer anorexia-cachexia syndrome (CACS)—a debilitating condition characterized by severe weight loss, muscle wasting, and reduced appetite. Currently, no approved therapies exist for CACS in the U.S., EU, or UK.
Patients receiving the highest dose of ART27.13 (1,300 µg) experienced an average weight gain of 6.4% over 12 weeks, compared with a 5.4% weight loss in the placebo group. Some patients achieved weight gains as high as 18.5%, versus just 0.4% on placebo. In addition, patients on ART27.13 showed a 4.2% increase in lean body mass after one month, while placebo patients lost an average of 3.2%. Activity levels, including moderate to vigorous physical activity, also improved—an important metric for regulators when evaluating therapies aimed at supportive care in oncology.
Safety findings were consistent with earlier studies. Most adverse events were mild to moderate, with only one reported case of severe malaise and no treatment-related serious adverse events, reaffirming the therapy’s tolerability in a fragile patient population.
CEO Gregory D. Weiss highlighted the results as a significant milestone: “With meaningful improvements in weight, muscle mass, and activity—combined with a favorable safety profile—ART27.13 is emerging as a differentiated candidate for one of oncology’s greatest unmet needs.” The company is now preparing for discussions with potential partners to support further development and accelerate the path toward registration studies.
Investor takeaway: These results strengthen confidence in ART27.13 as a first-in-class treatment for CACS. With no approved therapies, clear efficacy signals, and strong safety data, the asset is well positioned to attract licensing interest and create meaningful value as it advances toward pivotal trials.
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