Artelo Biosciences, Inc. ( ARTL ) stock is trading higher on Monday, with a session volume of 11.7 million, compared to the average volume of 70.3K, as per data from Benzinga Pro.

The company, which focuses on developing therapeutics that modulate lipid-signaling pathways, including the endocannabinoid system, announced favorable results Monday from its first-in-human study evaluating ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5).

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The results affirm a promising safety and pharmacokinetic (PK) profile previously observed in preclinical studies.

The Phase 1 Single Ascending Dose study was designed to assess the safety, tolerability, and pharmacokinetics of ART26.12 in healthy volunteers. The study enrolled 49 subjects.

The key findings include:

All adverse events (AEs) were mild, transient, and self-resolving. No drug-related AEs were observed in the blinded dataset, and no tolerability issues or safety signals were detected across multiple assessments (vital signs, ECGs, clinical laboratory tests, physical examinations, and visual analog mood scales).

Full dose-exposure profiles were successfully explored. Plasma analysis confirmed dose-dependent, linear absorption across the evaluated range.

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.

By targeting FABP5, ART26.12 modulates endogenous lipid signaling molecules that exert analgesic effects through established pathways, including TRPV1, PPAR alpha and cannabinoid receptors, with additional mechanisms such as Nav1.8 under investigation.

The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is expected to surpass $159 billion by 2030, driven by the increasing prevalence of conditions such as neuropathic pain, arthritis, and fibromyalgia.

A Multiple Ascending Dose study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing over time is expected to commence in the fourth quarter of this year.

Last week, Artelo Biosciences ( ARTL ) announced an at-the-market private placement for approximately $1.425 million in gross proceeds.

Artelo issued 136,844 shares and 93,179 pre-funded warrants and accompanying warrants to purchase 460,046 shares at $5.82 per share and 230,023 shares at $10.00 per share.

The offering will provide sufficient capital for Artelo to announce clinical data regarding its two Phase 1 study results for ART26.12 and a Phase 2 study readout from the CAReS trial for ART27.13.

Price Action: ARTL stock was up 192.9% at $19.89 at the last check on Monday.

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