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Artelo Biosciences Announces Expanded Clinical Data to be Presented on both ART26.12 and ART27.13 at the 8th Annual Cannabinoid & Endocannabinoid Drug Development Summit
Globenewswireยท 2025-10-15 13:15
Core Insights - Artelo Biosciences is advancing its clinical programs for two key drug candidates, ART26.12 and ART27.13, aimed at addressing significant medical needs in cancer-related conditions [1][4] Group 1: ART26.12 Development - ART26.12, a Fatty Acid Binding Protein 5 (FABP5) inhibitor, has shown no safety concerns and predictable linear plasma exposure in a Phase 1 Single Ascending Dose (SAD) study, with doses up to 1050 milligrams being safe and well tolerated [2][5] - The study indicated potential dosing flexibility for ART26.12 in both fed and fasted conditions, supporting its advancement into multiple ascending dose studies and proof-of-principle pain studies [2][5] Group 2: ART27.13 Development - Interim Phase 2 data from the Cancer Appetite Recovery Study (CAReS) showed that patients receiving ART27.13 gained over 6% in weight compared to placebo participants who lost an additional 5%, indicating a statistically significant effect [3][8] - ART27.13 is positioned as the most clinically advanced small-molecule treatment for cancer anorexia, with no approved treatments currently available in the US, UK, or EU [3][7] Group 3: Clinical Study Insights - The CAReS study is designed to evaluate ART27.13's effectiveness in improving lean body mass, weight gain, and appetite in cancer patients suffering from anorexia and weight loss [8] - The Phase 1 portion of CAReS established the safest initial dose for the Phase 2 stage, which is crucial for determining the drug's activity compared to placebo [8]