Artelo Biosciences has initiated a Phase 1 clinical trial of ART26.12, its lead FABP5 inhibitor, marking the first time a selective FABP5 inhibitor has been administered to humans. The company expects initial safety and pharmacokinetic data in the first half of 2025. This trial focuses on evaluating ART26.12 as a non-opioid treatment for various pain conditions, including chemotherapy-induced peripheral neuropathy (CIPN), diabetic neuropathy, cancer bone pain, and osteoarthritis.
This advancement signifies a potential turning point in pain management. Current CIPN treatments are often ineffective and carry significant side effects, creating a substantial unmet medical need. A successful non-opioid treatment like ART26.12 could significantly improve the quality of life for cancer patients experiencing CIPN, allowing for better tolerance of chemotherapy and potentially improving treatment outcomes. Furthermore, the potential applications extend to other prevalent pain conditions, representing a significant market opportunity.
ART26.12 targets FABP5, an intracellular protein involved in lipid signaling. Preclinical studies have shown promising results across various pain models. The current Phase 1 single ascending dose study aims to determine appropriate doses for a subsequent multiple ascending dose study in healthy volunteers planned for the second half of 2025. This phased approach allows for careful evaluation of safety and pharmacokinetic properties before proceeding to larger trials.
The progress of ART26.12 represents a significant step forward for Artelo Biosciences and the field of pain management. Positive results from this Phase 1 trial would validate the FABP inhibition mechanism and could pave the way for further clinical development, potentially leading to a novel class of non-opioid pain therapeutics. The upcoming data readout in the first half of 2025 will be a critical inflection point, providing key insights into the future of this promising drug candidate.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
