Artelo Biosciences Receives FDA Clearance for its ART26.12 IND Application

July 15, 2024

DENVER, Colo., Jul 15, 2024 (247marketnews.com)- Artelo Biosciences, Inc. (Nasdaq:ARTL) stated that the U.S. Food and Drug Administration (FDA) issued a “Study May Proceed” letter for the Company’s ART26.12 Investigational New Drug (IND) application, for the treatment of chemotherapy-induced peripheral neuropathy (CIPN), which enables the Company to initiate its first-in-human Phase 1 single ascending dose study.

ART26.12 is the lead compound in Artelo Biosciences’ proprietary Fatty Acid Binding Protein (FABP) platform and the first selective FABP5 inhibitor to enter clinical trials and study startup activities are happening in collaboration with contract research organization Worldwide Clinical Trials.

Gregory D. Gorgas, President and CEO of Artelo Biosciences, stated, “Receiving IND clearance validates our development efforts and underscores the potential impact of ART26.12 to improve patients’ lives.

“We look forward to sharing the initial clinical results with ART26.12 next year. As the leading company pursuing FABP inhibiton 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.”

 

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

ART26.12 is the lead compound in Artelo Biosciences’ proprietary Fatty Acid Binding Protein (FABP) platform and the first selective FABP5 inhibitor to enter clinical trials and study startup activities are happening in collaboration with contract research organization Worldwide Clinical Trials.

Gregory D. Gorgas, President and CEO of Artelo Biosciences, stated, “Receiving IND clearance validates our development efforts and underscores the potential impact of ART26.12 to improve patients’ lives.

“We look forward to sharing the initial clinical results with ART26.12 next year. As the leading company pursuing FABP inhibiton 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.”

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