Neuropathy treatment has taken a significant step forward with the FDA’s clearance of 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). This clearance allows Artelo Biosciences to proceed to a Phase I single ascending dose study for ART26.12 in patients with CIPN. The study will be conducted in partnership with Worldwide Clinical Trials.
“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 of Artelo Biosciences. “We look forward to sharing the initial clinical results with ART26.12 next year. As the leading company pursuing FABP inhibition, 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.”
Neuropathy Treatment Innovation: ART26.12 Enters Clinical Trials as First Selective FABP5 Inhibitor
ART26.12 is the first selective FABP5 inhibitor to enter clinical trials, representing a novel, non-opioid approach to managing painful neuropathies. Artelo Biosciences noted that its FABP inhibitor platform has shown promising preclinical efficacy and has attracted significant interest due to its unique mechanism and patent position.
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 treating multiple cancers, painful neuropathies, cancer bone pain, dermatologic conditions, and anxiety disorders.
Chemotherapy-induced peripheral neuropathy is a common side effect of certain chemotherapy drugs. 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 like bortezomib and lenalidomide. CIPN is influenced by factors such as 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 chemotherapy-induced peripheral neuropathy several years after treatment.
Neuropathy Risk: JCO Global Oncology Study Finds High CIPN Prevalence in Cisplatin Chemotherapy Patients in Kenya
Another study by JCO Global Oncology involving 67 patients undergoing chemotherapy with cisplatin in Kenya aimed to determine the prevalence, predictors, and risk factors of CIPN. The study found that 83.6% of participants had chemotherapy-induced peripheral neuropathy, with most cases being mild to moderate. Only two cases were reported as grade 4 neuropathy. Additionally, 74% of patients were receiving cisplatin combined with another neurotoxic chemotherapeutic agent, commonly taxane, which was used in 44 patients.
“Our study found the prevalence rate of CIPN to be 83.6%, of which most patients had mild to moderate peripheral neuropathy,” the study authors reported. “The prevalence rate of CIPN ranges from 20% to 90%. This wide range may be influenced by several factors such as study population, length of follow-up, chemotherapy regimen, and assessment tools used.”
The FDA previously granted Orphan Drug Designation for DSP-5336 for the indication of acute myeloid leukemia in June 2022. The promising data from an ongoing Phase I/II study, presented at the European Hematology Association 2024 Hybrid Congress, demonstrated an objective response rate of 57% and a 24% rate of complete remission or partial hematologic recovery for the treatment.
There were no reports of dose-limiting toxicity or significant adverse events, and the treatment was well tolerated. Additionally, there were no serious drug-drug interactions or need for differentiation syndrome prophylaxis, with only three manageable cases of differentiation syndrome.
“Management of AML continues to be challenging with limited options for which there are currently no approved targeted therapies to treat AML with KMT2A (MLL) rearrangements or NPM1 mutations, leaving a serious unmet medical need,” said Jatin Shah, MD, chief medical officer—oncology at SMPA. “DSP-5336 has shown promising clinical activity, and menin inhibitors have tremendous potential to impact the outcomes of these types of acute leukemia. We are excited by these early results and FDA Fast Track Designation and look forward to working closely with the agency and our collaborators to rapidly advance this program with the goal of providing a well-tolerated and effective targeted treatment option for patients with relapsed or refractory acute myeloid leukemia.”
Resource: Artelobio, July 15, 2024
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