Artelo Biosciences Announces New Data from an Initial Food Effect Investigation with ART26.12, a Novel Non-Opioid Treatment Candidate for Persistent Pain

Core Insights - Artelo Biosciences, Inc. has announced positive results from its preliminary food effect evaluation of ART26.12, a selective oral small molecule fatty acid binding protein 5 (FABP5) inhibitor, which is aimed at treating various conditions including cancer and pain [2][5] - The single ascending dose (SAD) Phase 1 clinical trial showed no drug-related adverse events, indicating a favorable safety profile for ART26.12 [3][8] - The company is preparing to initiate a multiple ascending dose (MAD) study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing [6] Safety and Pharmacokinetics - The food effect study assessed the pharmacokinetics and safety profile of ART26.12 in healthy volunteers under both fed and fasted conditions, confirming that dosing can occur in either state [3][5] - Participants in the SAD study received three single doses of ART26.12 with no serious adverse events reported, and all adverse events were mild and self-limiting [8] - Data indicated consistent exposure levels under fasted conditions, suggesting low inter-subject variability and effective administration with or without food [8] Clinical Development - The results from the SAD and food effect study provide a strong foundation for advancing to the upcoming MAD study, which is planned to commence in the fourth quarter of this year [6][8] - ART26.12 represents a new therapeutic class with a non-opioid, non-steroidal analgesic approach targeting novel mechanisms in pain modulation [7] - The initial clinical development is focused on chemotherapy-induced peripheral neuropathy (CIPN), with potential applications in other conditions such as cancer and anxiety disorders [7] Company Overview - Artelo Biosciences is dedicated to developing therapeutics that modulate lipid-signaling pathways, addressing significant unmet needs in various medical conditions [9] - The company is also leveraging a digital asset treasury strategy to enhance liquidity management and support its therapeutic programs [9]