Artelo Biosciences Advances ART26.12 Into MAD Study

A non-opioid analgesic mechanism with first-in-human safety data now moves toward dose escalation: Artelo Biosciences is preparing to initiate a Phase 1 multiple ascending dose (MAD) study for ART26.12 in Q4 2026, following a single ascending dose (SAD) study that reported no serious adverse events and dose-proportional pharmacokinetics across fed and fasted conditions.

Professor Saoirse O'Sullivan, Vice President of Translational Sciences at Artelo, presented the ART26.12 program on October 29 at the IASP 2026 World Congress on Pain in Bangkok, Thailand. The presentation, titled "ART26.12; a Peripherally Acting, Non-Opioid, Non-Steroidal Analgesic for Peripheral Neuropathy," introduced the compound as the first selective Fatty Acid Binding Protein 5 (FABP5) inhibitor to enter human clinical studies. For regulatory affairs leads tracking non-opioid IND submissions, the SAD dataset now provides a documented safety margin and preliminary food-effect profile that will anchor the MAD protocol design.

ART26.12 is orally administered and peripherally acting, with nonclinical data spanning chemotherapy-induced peripheral neuropathy (CIPN) alongside paclitaxel and oxaliplatin, diabetic neuropathy, cancer-induced bone pain, and spinal cord injury models. In a four-week osteoarthritis study, oral ART26.12 reduced pain comparably to naproxen with significantly less gastric tissue damage in treated animals. The breadth of nonclinical models will inform indication sequencing and the scope of future IND amendments as the program expands beyond CIPN.

For CMC and API planning teams, the confirmed oral route and fed/fasted flexibility narrow formulation variables ahead of MAD-stage manufacturing scale-up. Process validation timelines for a first-in-class small molecule at this stage typically align with Phase 2 entry, making Q4 2026 MAD initiation a near-term trigger for early ICH Q10-aligned quality system documentation.

The MAD study outcome will establish the tolerability range and pharmacokinetic profile needed to support a Phase 2 proof-of-concept design in CIPN, the primary indication currently guiding Artelo's regulatory strategy.

Source: Artelo Biosciences, Inc. via GlobeNewswire, October 26, 2026.