Artelo Biosciences Announces New Data From Initial Food Effect Investigation With a Novel Non-Opioid Treatment Candidate for Persistent Pain

Artelo Biosciences, Inc. recently 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 (SAD) Phase 1 clinical trial evaluating ART26.12, the first selective oral small molecule fatty acid binding protein 5 (FABP5) 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:

• Favorable Safety Profile: 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.
• Predictable Pharmacokinetics: 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.
• Clinical Development Momentum: The profile observed from the SAD and Food Effect study provides a strong foundation for advancing to the upcoming multiple ascending dose (MAD) study.

“We are delighted to have successfully concluded our initial step in the human investigation of ART26.12. The SAD and Food Effect study provides us with the knowledge that we can choose to dose in both the fed or fasted state in future trials,” said Andrew Yates, PhD, Senior Vice President and Chief Scientific Officer at Artelo. “The results generated to date provide our first indication of predictable pharmacokinetic behavior and a benign safety profile—both of which are highly desirable in a pain drug intended for chronic use,” continued Dr. Yates.

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.

ART26.12 is a selective, orally administered, and peripherally acting FABP5 inhibitor. ART26.12 represents a new therapeutic class with a non-opioid, non-steroidal analgesic approach designed to target a novel mechanism in pain modulation by altering endogenous lipid species in pain-relevant tissues. These lipid messengers influence multiple known pain pathways, including transient receptor potential vanilloid 1 (TRPV1), peroxisome proliferator-activated receptor alpha (PPAR-α), and cannabinoid receptors, with emerging evidence of modulation of additional targets such as Nav1.8. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). FABPs are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in several pathologies. In addition to ART26.12 in CIPN, Artelo’s extensive and proprietary library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. The U.S. National Institutes of Health (NIH) has included ART26.12 in its Helping to End Addiction Long-term^® (HEAL) initiative’s Preclinical Screening Platform for Pain (PSPP) program. Through the HEAL PSPP, the NIH is dedicated to advancing non-opioid solutions to pain and curbing opioid use disorder.

Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Complementing its scientific innovation, Artelo adopted a forward-looking corporate finance initiative whereby it is deploying a portion of its excess capital into Solana under a digital asset treasury strategy. Artelo intends to leverage Solana to diversify its balance sheet, enhance liquidity management, and position the Company for long-term value creation to support its therapeutic programs. Led by an experienced executive team collaborating with world-class researchers and digital-asset technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices to maximize stakeholder value. More information is available at www.artelobio.com.