Tingling and numbness are two of the symptoms of chemotherapy-induced peripheral neuropathy. Image credit: Shutterstock / Zay Nyi Nyi.

The US Food and Drug Administration (FDA) has approved Artelo Biosciences’ investigational new drug (IND) application, greenlighting a Phase I trial for the pharma company’s fatty acid binding protein (FABP) inhibitor.

ART26.12, Artelo’s lead asset, is the first selective FABP5 inhibitor to enter clinical trials, according to the US-based company. The Phase I single ascending dose study will evaluate the drug in the treatment of chemotherapy-induced peripheral neuropathy.

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Chemotherapy-induced peripheral neuropathy is a risk in patients undergoing treatment for cancer. Certain chemotherapy drugs such as platinum-based compounds, taxanes, and vinca alkaloids, among others, are more likely to cause damage to peripheral nerves. Patients with the condition experience symptoms such as tingling, pain, muscle weakness, and dizziness.

There is currently no FDA-approved treatment for chemotherapy-induced peripheral neuropathy.

Artelo is developing ART26.12 as a non-opioid approach for managing painful neuropathies. The drug targets FABP5, an intracellular protein involved in lipid signalling. FABPs are lipid carriers that play a role in inflammation.

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The company expects results from the Phase I trial, which is being conducted with the CRO Worldwide Clinical Trials, in the first half of 2025.

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Artelo’s CEO Gregory Gorgas said: “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.”

A FABP3 has previously been studied in patients with peripheral arterial disease (PAD). The study, conducted at St Michael’s Hospital in Ontario, Canada, demonstrated a diagnostic and prognostic biomarker use for FABP3 levels in PAD patients.

FABP5/FABP7 inhibitors have also been hinted as having potential therapeutic potential in multiple sclerosis, based on mouse models.