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Artelo Biosciences Completes Positive Pre-IND Meeting with FDA for ART26.12
Announces Plans to File IND Application in Neuropathic Pain SOLANA BEACH, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL),
About this update from Artelo Biosciences, Inc.
[{"type":"text","content":"Announces Plans to File IND Application in Neuropathic Pain\nSOLANA BEACH, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced it has completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the manufacturing, preclinical and clinical development plan for ART26.12. Based on the FDA’s feedback, the Company also announced that it plans to file an IND application for the use of ART26.12 in neuropathic pain in the first half of 2024. ART26.12 is a potential first-in-class orally administered Fatty Acid Binding Protein 5 (FABP5) inhibitor drug, initially under development for the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy. The FDA reviewed the IND-enabling preclinical data, manufacturing plans, and clinical study protocol synopses, provided guidance, and answered Artelo's questions on the development plan. “We greatly value the FDA's guidance as we complete our remaining IND-enabling studies,\" said Dr. Andrew Yates, Chief Scientific Officer at Artelo Biosciences. \"The guidance we received was positive and validating as we prepare to advance ART26.12 into the clinic.” Gregory Gorgas, CEO of Artelo Biosciences, further noted, “We look forward to filing an IND application in order to obtain clearance for the first-in-human ART26.12 Phase 1 clinical trial. Importantly, based on our preclinical studies, we believe ART26.12 holds the promise to address a variety of painful neuropathies, whether they are caused by chemotherapy or are disease related such as diabetic neuropathy.” According to Persistence Market Research, the global neuropathic pain market was approximately $7.6 billion in 2022 and is expected to exceed $14 billion by the end of 2033. About ART26.12Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids including endocannabinoids and fatty acids. Various inhibitors of FABPs may be particularly useful for the treatment of specific cancers, neuropathic and nociceptive pain, and anxiety disorders. ART26.12, Artelo’s lead FAB...