Artelo Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a ?Study May Proceed? letter for the Company?s Investigational New Drug (IND) application for ART26.12, for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). FDA clearance of the ART26.12 IND application enables the Company to initiate its first-in-human Phase 1 single ascending dose study.

Study startup activities have been initiated in collaboration with the internationally known contract research organization Worldwide Clinical Trials. ART26.12 is the lead compound in the Company?s proprietary Fatty Acid Binding Protein (FABP) platform and the first selective FABP5 inhibitor to enter clinical trials. The FABP5 target is an intracellular protein involved in lipid signaling and represents a promising mechanism of action for drug candidates that can modify the cellular lipidome.

ART26.12 is being developed as a non-opioid approach to the management of painful neuropathies. The Company?s FABP inhibitor platform, and ART26.12 in particular, has garnered interest from a range of potential partners due to its preclinical demonstation of efficacy, novel mechanism, and strong patent estate.