FDA Clears Artelo Biosciences’ Investigational New Drug Application for Chemotherapy-Induced Peripheral Neuropathy Treatment

Image Credit: Abobe Stock Images/Khunatorn

The FDA has granted clearance to Artelo Biosciences’ Investigational New Drug (IND) application for ART26.12, a selective fatty acid binding protein 5 (FABP5) inhibitor for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). According to the company, the FDA clearance will allow them to proceed to a Phase I single ascending dose study for ART26.12 in patients with CIPN. Additionally, the study is being conducted in partnership with Worldwide Clinical Trials.¹

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

According to Artelo Biosciences, ART26.12 is the first selective FABP5 inhibitor to enter clinical trials, representing a novel, non-opioid approach to managing painful neuropathies. Further, the company stated that its FABP inhibitor platform has shown promising preclinical efficacy and has attracted significant interest due to its unique mechanism and patent position. Currently, it’s the lead compound in Artelo’s proprietary FABP platform. The inhibitor is being developed as an orally delivered, peripherally acting, non-opioid, new chemical entity. Preclinical evidence suggests that FABP inhibitors have broad therapeutic promise for the treatment of multiple cancers, painful neuropathies, cancer bone pain, dermatologic conditions, and anxiety disorders, Artelo Biosciences stated in the press release.¹

In a 2017 study published by the Oncology Nursing Society, a systematic review and meta-analysis involving 4,179 patients found CIPN prevalence at 68% in the first month after chemotherapy, 60% within three months, and 30% within six months or longer, with prevalence associated with different chemotherapy drugs. Chemotherapies that lead to CIPN included platinum-based agents, taxanes, epothilones, vinca alkaloids, and newer agents, such as bortezomib and lenalidomide. According to the study authors, CIPN is influenced by age, type of chemotherapy, dose, intensity, cumulative dose, therapy duration, and preexisting diseases. Thirty percent of patients with cancer who receive taxanes still suffer from CIPN several years after the treatment.²

In another study by JCO Global Oncology, 67 patients who were undergoing chemotherapy with cisplatin were recruited to determine the prevalence, predictors, and/or risk factors of CIPN in patients undergoing chemotherapy with cisplatin in Kenya. Results in this study found that 83.6% of those involved had CIPD. Additionally, 81% only had mild-grade CIPN, with only two reports of grade 4 neuropathy. Investigators also found that 74% of patients were receiving cisplatin combined with another neurotoxic chemotherapeutic agent, and the most common combined neurotoxic chemotherapeutic drug was taxane, which accounted for 44 patients.³

“Our study found the prevalence rate of CIPN to be 83.6%, of which most patients had mild to moderate peripheral neuropathy,” reported the authors of the study. “The prevalence rate of CIPN ranges from 20% to 90%.10-17 This wide range may be influenced by several factors such as study population, length of follow-up, chemotherapy regimen, and assessment tools used.

References

1. Artelo Biosciences Receives FDA Clearance of its IND Application for ART26.12, a Selective Fatty Acid Binding Protein 5 Inhibitor. 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. Chemotherapy-Induced Peripheral Neuropathy Assessment Tools: A Systematic Review. ONS. Accessed July 15, 2024. https://www.ons.org/onf/44/3/chemotherapy-induced-peripheral-neuropathy-assessment-tools-systematic-review#:~:text=A%20systematic%20review%20and%20meta,et%20al.%2C%202014

3. Prevalence and Predictors of Cisplatin-Induced Peripheral Neuropathy at the Kenyatta National Hospital. ASCO Publications. September 3, 2019. Accessed July 15, 2024. https://ascopubs.org/doi/10.1200/JGO.19.00097#:~:text=9,patients%20who%20had%20finished%20chemotherapy.