Artelo Biosciences announces data on food effect evaluation with ART26.12

Artelo Biosciences (ARTL) announced encouraging results from its preliminary food effect evaluation with ART26.12. This assessment was conducted as a part of the successful single ascending dose Phase 1 clinical trial evaluating ART26.12, the first selective oral small molecule fatty acid binding protein 5 inhibitor dosed in the clinic. The food effect interrogation was designed to assess the pharmacokinetics and safety profile ART26.12 in healthy volunteers under both fed and fasted conditions. The selected dose was based on previously established safety and pharmacokinetic data from the SAD study, where there were no drug-related adverse events reported. Key findings include: Participants received three single doses of ART26.12 separated by 7-day intervals. No serious adverse events, safety concerns, or tolerability issues were identified. All reported adverse events were mild, self-limiting, and consistent with those observed in the SAD study. Data showed consistent exposure levels under fasted conditions across the both the food effect evaluation and SAD study, indicating low inter-subject variability. Plasma pharmacokinetics further suggest ART26.12 can be effectively administered with or without food. The profile observed from the SAD and Food Effect study provides a strong foundation for advancing to the upcoming multiple ascending dose study. Preparations are underway to initiate a MAD study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing over time. The MAD study is planned to commence dosing subjects in the fourth quarter this year.