New Drug Originally Developed at Stony Brook Gets FDA Clearance

Iwao Ojima (left) and Martin Kaczochaled the Stony Brook team in developing its class of Fatty Acid Binding Proteins (FABPs) a promising set of drug targets for new therapies. Photo by John Griffin.

The FABP inhibitor is part of a series of compounds to help curb pain and inflammation related to cancer treatment

Six years ago, Stony Brook University - through the Research Foundation for the State University of New York - licensed a promising technology to Artelo Biosciences that identified Fatty Acid Binding Proteins (FABPs) as drug targets of the body's endocannabinoid system for a potentially promising way to treat pain, inflammation and cancer. Now, the first of these compounds has been cleared by the Food and Drug Administration (FDA) for human clinical trials.

Artelo announced this week that the FDA's initial approval of one of the FABP5 (5 indicates a specific protein) selective compounds called ART26.12 enables the company to initiate its first human phase 1 single ascending dose study of the drug. The company states that ART26.12 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.

ART26.12 is the lead compound in the series of FABP5 inhibitors under development. In 2018, Artelo received an exclusive license to the intellectual property of all FABP inhibitors for the modulation of the endocannabinoid system.

The work on FABPs originated with Iwao Ojima, SUNY Distinguished Professor in the Department of Chemistry at Stony Brook University; Martin Kaczocha, associate professor in the Department of Anesthesiology in the Renaissance School of Medicine at Stony Brook University; and Dale Deutsch, Professor Emeritus in the Department of Biochemistry and Cell Biology at Stony Brook University, a research collaboration affiliated with the Institute of Chemical Biology and Drug Discovery (ICB & DD).

The team identified the action of FABPs as drug targets. Specifically, FABP5 was identified as the intracellular transporter for the endocannabinoid anandamide (AEA), a neurotransmitter produced in the brain that binds to cannabinoid receptors.

The research group demonstrated in the laboratory that elevated levels of endocannabinoids can result in beneficial pharmacological effects on stress, pain and inflammation and also ameliorate the effects of drug withdrawal. Ojima (also director of the ICB & DD), Kaczocha, Deutsch and colleagues discovered that by inhibiting FABP transporters, the level of AEA is raised. The finding provided the basis for the drug development approach to elevate the levels of AEA.

Artelo took this concept and approach to further develop the compounds. Their scientists collaborated with the Stony Brook team to reach new findings that has led to the commercialization and use of the first drug (ART26.12) in a potential pipeline of drugs to treat pain and inflammation.

After the license to Artelo was finalized, Ojima and Kaczocha, under a contract with Artelo, synthesized and evaluated compound candidates with high FABP5 potency and selectivity, an effort that culminated in the development of the lead candidate, SB-FI-1621, which Artelo named ART26.12.

"This is the first clinical stage compound targeting the FABP pathway, an important and exciting milestone," said Sean Boykevisch, director of Intellectual Property Partners in Stony Brook's Technology Transfer Office. "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."

"We look forward to sharing the initial clinical results with ART26.12 next year," said Gregory D. Gorgas, president and CEO of Artelo Biosciences. "As the leading company pursuing FABP inhibition we are 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."

Learn more about the Stony Brook research that developed FABP inhibitors and the grant to support years of research, and get more details on the FDA clearance news of the drug and Artelo's R&D plan.

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