New drug developed at Stony Brook University gets FDA clearance

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A new pain-relief drug originally developed at Stony Brook University is one step closer to coming to market. The first compound from this technology has received clearance by the U.S. Food and Drug Administration for human clinical trials. The drug is designed to control pain related to cancer treatment.

Stony Brook University, through the Research Foundation for the State University of New York, licensed the technology six years ago to Artelo Biosciences, which has locations in California and England. That technology identified Fatty Acid Binding Proteins (FABPs) as drug targets of the body’s endocannabinoid system for a potentially promising way to treat pain and inflammation. Artelo scientists collaborated with Stony Brook researchers to reach new findings that has led to the commercialization and use of the first compound in a potential pipeline of drugs to treat pain and inflammation.

Artelo announced this week that the FDA’s initial approval of one of the candidate compounds enables the company to initiate its first human phase 1 single ascending dose study of the drug. It will address a critical need for cancer patients, treating chemotherapy-induced peripheral neuropathy. Phase 1 clinical trials are expected to be launched internationally during the first half of 2025.

“This is the first clinical stage compound targeting the FABP pathway, an important and exciting milestone,” Sean Boykevisch, director of Intellectual Property Partners in Stony Brook’s Technology Transfer Office, said in a news release about the FDA clearance.

“The fundamental and translational research conducted by the Stony Brook team and their subsequent collaboration with Artelo resulted in a true bench-to-bedside program with the goal of better patient experiences and outcomes,” Boykevisch added.

“We look forward to sharing the initial clinical results with ART26.12 next year,” Gregory Gorgas, president and CEO of Artelo Biosciences, said in the news release.

Gorgas said that the company is “committed to building on the unique, lipid-modulating mechanism of our FABP inhibitor platform to address life-altering pathologies for which there are few, if any, safe and effective pharmaceutical treatments.”