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Investing.com -- Artelo Biosciences Inc (NASDAQ:ARTL) stock surged over 100% following favorable results from its first-in-human study evaluating ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5).
The clinical-stage pharmaceutical company’s Phase 1 Single Ascending Dose study, which enrolled 49 subjects, demonstrated an excellent safety profile with only mild, transient, and self-resolving adverse events. No drug-related adverse events were observed in the blinded dataset, and no tolerability issues or safety signals were detected across multiple assessments.
The study also confirmed predictable pharmacokinetics with dose-dependent, linear absorption across the evaluated range. Additionally, a wide safety margin was observed between estimated therapeutic plasma concentrations and the highest exposure levels achieved, supporting potential titration for maximum efficacy in future studies.
ART26.12 is the first orally administered, selective, and peripherally restricted FABP5 inhibitor to enter human clinical evaluation. The compound works by modulating endogenous lipid signaling molecules that exert analgesic effects through established pathways, including TRPV1, PPAR alpha, and cannabinoid receptors.
The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is expected to surpass $159 billion by 2030. Artelo plans to commence a Multiple Ascending Dose study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing in the fourth quarter this year.
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