Core Insights - Artelo Biosciences, Inc. presented interim data from its Phase 2 Cancer Appetite Recovery Study (CAReS) for ART27.13, showing significant improvements in weight, lean body mass, and daily activity in patients with cancer anorexia-cachexia syndrome (CACS) [1][2][4] Summary by Sections Interim Data Highlights - Patients treated with the highest dose of ART27.13 (1300 µg) achieved an average weight gain of +6% over 12 weeks, while placebo patients lost approximately 5% [7] - Improvements in lean body mass were consistent with total weight gains, indicating muscle preservation or accrual [7] - Digital wearable data confirmed that treated patients exhibited greater daily activity metrics compared to placebo [7] - ART27.13 maintained a favorable safety profile, with adverse events primarily mild to moderate and no serious drug-related events reported [7][8] About ART27.13 - ART27.13 is a novel benzimidazole derivative and dual cannabinoid agonist, designed for once-daily oral administration, targeting peripheral CB1 and CB2 receptors [6] - The drug aims to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients [6] - Previous studies have shown a statistically significant and dose-dependent increase in body weight in healthy individuals with back pain [6] About CAReS - The CAReS study is a Phase 1/2 randomized, placebo-controlled trial assessing ART27.13 in patients with cancer anorexia and weight loss [9] - Anorexia and weight loss in cancer patients can lead to weakened immune systems and increased discomfort, with a weight loss of over 5% predicting poorer outcomes [9][10] - The Phase 2 stage aims to evaluate ART27.13's effectiveness in improving lean body mass, weight gain, and anorexia compared to placebo [9] Market Opportunity - CACS affects up to 80% of patients with advanced cancer, representing a market opportunity exceeding $3 billion [10] - Currently, there are no FDA-approved treatments for cancer anorexia-cachexia syndrome in the US, UK, or EU [10] Company Overview - Artelo Biosciences is focused on developing therapeutics that modulate lipid-signaling pathways, addressing significant unmet needs in various conditions including anorexia and cancer [11] - The company collaborates with world-class researchers and applies rigorous scientific and regulatory practices to maximize stakeholder value [11]