FDA Clears Artelo Biosciences' IND Application for ART26.12

Artelo Biosciences, Inc., a clinical-stage pharmaceutical company listed on Nasdaq, has announced that the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application for ART26.12, intended for treating chemotherapy-induced peripheral neuropathy (CIPN). This FDA approval allows the company to start a Phase 1 clinical trial, which will be conducted in collaboration with Worldwide Clinical Trials. ART26.12 marks the first selective Fatty Acid Binding Protein 5 (FABP5) inhibitor to reach clinical trials.

ART26.12 is the lead candidate of Artelo's proprietary FABP inhibitor platform, which aims to modulate lipid signaling pathways. The compound is seen as a promising non-opioid treatment for painful neuropathies. The FABP5 target is an intracellular protein involved in lipid signaling, offering a novel mechanism of action for drug candidates that can modify the cellular lipidome. The platform has gained attention from potential partners, thanks to its efficacy demonstrated in preclinical trials, its unique mechanism, and strong patent protection.

Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences, commented on the IND clearance, stating it underscores the potential impact of ART26.12 in improving patients' lives. He emphasized the company's commitment to advancing its lipid-modulating FABP inhibitor platform to tackle severe medical conditions that currently lack safe and effective treatments. The first clinical results for ART26.12 are anticipated in the first half of 2025.

Fatty Acid Binding Proteins (FABPs) are a group of intracellular proteins that help transport lipids involved in cellular signaling. Overexpression of FABPs is often linked to abnormal lipid signaling in various diseases. ART26.12 is a potent and selective small molecule inhibitor of FABP5, designed as an orally administered, peripherally acting, non-opioid treatment. Developed by Distinguished Professor Iwao Ojima and Professor Martin Kaczocha at Stony Brook University, the extensive library of FABP inhibitors was exclusively licensed to Artelo, granting them global rights. Preclinical data suggest that FABP inhibition has the potential to treat multiple cancers, painful neuropathies, cancer-related bone pain, dermatologic conditions, and anxiety disorders.

Chemotherapy-induced peripheral neuropathy (CIPN) is a type of neuropathic pain caused by chemotherapy treatments, which can occur with a frequency as high as 90%. CIPN often leads to reducing or stopping cancer treatments, negatively affecting their efficacy and patient survival. Acute CIPN manifests during chemotherapy, while chronic CIPN can persist for months to years. Currently, no FDA-approved treatment exists for CIPN. A new treatment or preventive measure for CIPN could not only alleviate severe pain but also enable the continuation of essential cancer therapies.

Artelo Biosciences, Inc. focuses on developing and commercializing proprietary therapeutics that modulate lipid-signaling pathways. The company's portfolio includes versatile product candidates aimed at addressing significant unmet medical needs across various diseases and conditions, such as anorexia, cancer, anxiety, dermatologic issues, pain, and inflammation. Led by experienced biopharmaceutical executives and collaborating with respected researchers and technology experts, Artelo utilizes state-of-the-art scientific, regulatory, and commercial strategies to develop impactful therapies.