FDA Clears IND for Selective Fatty Acid Binding Protein 5 Inhibitor, ART26.12, Phase I Study to Commence

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The FDA has cleared Artelo Biosciences’ Investigational New Drug application (IND) for ART26.12, a selective fatty acid binding protein (FABP) 5 inhibitor for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). A first-in-human Phase I single ascending dose study of the inhibitor is now cleared to begin.¹

Earlier this year in January, Artelo announced it had chosen contract research organization, Worldwide Clinical Trials to support the upcoming Phase I trial.²

ART26.12 is the lead compound in Artelo’s proprietary FABP platform and the first selective FABP5 inhibitor to enter clinical trials. It is being developed as a non-opioid approach to the management of painful neuropathies. 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.

According to the American Cancer Society, CIPN is brought on by medicines used to cure cancer. These medicines can damage the peripheral nervous system, which sends signals between the central nervous system and all other parts of the body. Platinum drugs such as cisplatin, carboplatin, and oxaliplatin are among some of the most likely cancer medicines that can cause CIPN.³

“Receiving IND clearance validates our development efforts and underscores the potential impact of ART26.12 to improve patients’ lives,” Gregory D. Gorgas, president and chief executive officer of Artelo Biosciences said in a press release. “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 shared preclinical data on ART26.12 in breast cancer-induced bone pain earlier in July. According to the data, ART26.12 was effective in reducing pain behaviors induced by breast cancer. The preclinical data was from the fourth in a series of pain models that demonstrated similar activity with ART26.12.⁴

“ART26.12 continues to deliver positive preclinical efficacy data to support its development as a novel non-opioid, non-steroidal analgesic treatment,” Professor Saoirse O’Sullivan, vice president of translational sciences at Artelo said in an earlier press release.

References

1. Artelo Biosciences Receives FDA Clearance of its IND Application for ART26.12, a Selective Fatty Acid Binding Protein 5 Inhibitor. News release. Artelo Biosciences. July 15, 2024. Accessed July 15, 2024. https://ir.artelobio.com/news-events/press-releases/detail/132/artelo-biosciences-receives-fda-clearance-of-its-ind

2. Artelo Biosciences Announces Selection of Worldwide Clinical Trials as Clinical Research Organization to Support First-in-Human Study of ART26.12. News release. Artelo Biosciences. January 8, 2024. Accessed July 15, 2024. https://ir.artelobio.com/news-events/press-releases/detail/118/artelo-biosciences-announces-selection-of-worldwide

3. Peripheral Neuropathy. American Cancer Society. March 29, 2024. Accessed July 15, 2024. https://www.cancer.org/cancer/managing-cancer/side-effects/pain/peripheral-neuropathy.html

4. Artelo Biosciences Presents Preclinical Data on ART26.12 in Breast Cancer-Induced Bone Pain at the 34th Annual International Cannabinoid Research Society Symposium. News release. Artelo Biosciences. July 1, 2024. Accessed July 15, 2024. https://ir.artelobio.com/news-events/press-releases/detail/129/artelo-biosciences-presents-preclinical-data-on-art26-12-in