Artelo Biosciences' investigational drug, ART26.12, a non-opioid compound targeting neuropathic pain, has advanced to the next stage of its Phase 1 clinical trial after a positive safety review. The study's Safety Review Committee (SRC) analyzed data from the initial group of volunteers and recommended escalating to the next dosage level.
ART26.12 is being developed by Artelo Biosciences, a company based in Solana Beach, California. The drug was originally discovered and developed at Stony Brook University by Iwao Ojima, PhD, and Martin Kaczocha, PhD. The underlying technology involves fatty acid binding protein (FABP) inhibitors, with ART26.12 being a lead candidate. Artelo Biosciences secured the rights to the technology in 2018 through a licensing agreement with the Research Foundation for the State University of New York.
Addressing Neuropathic Pain
Neuropathic pain affects an estimated 8% of the U.S. population, which equates to approximately 20 million individuals. ART26.12 is specifically being developed to treat chemotherapy-induced peripheral neuropathy (CIPN), a significant adverse effect experienced by cancer patients during and after therapy. Current treatments for CIPN are limited, and there are no FDA-approved therapies specifically for this condition.
Mechanism of Action
Dr. Ojima and his team identified FABPs as potential drug targets within the body's endocannabinoid system. By modulating lipids within cells, FABP inhibitors offer a promising approach to treating pain, inflammation, and cancer. Artelo Biosciences highlights ART26.12 as the leading compound within their FABP platform and believes it is the first selective FABP5 inhibitor to enter clinical trials.
Clinical Trial Progress
The SRC recently concluded its initial safety assessment of ART26.12, reviewing data from the first cohort of eight volunteers in early January. The Phase 1 trial will now proceed to the next phase, which will involve a larger number of participants and an evaluation of higher doses of the investigational drug. Artelo Biosciences anticipates that other potential applications for ART26.12 and other FABP5 inhibitors under development include treatments for cancer, osteoarthritis, psoriasis, and anxiety.
Expert Insights
"We are pleased to report on the progress with ART26.12, our lead FABP inhibitor," said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. "Based on the encouraging safety profile of ART26.12 in preclinical studies, we look forward to learning from the initial safety, pharmacokinetic, and biomarker data from this ongoing human study, which is expected to be completed during the first half of 2025."
