Artelo Biosciences (ARTL) said Monday it has received a "Study May Proceed" notification from the US Food and Drug Administration regarding its investigational new drug application for ART26.12 to potentially treat chemotherapy-induced peripheral neuropathy.
With the FDA clearance, a phase 1 single ascending dose study in humans may proceed, with the results expected in the first half of 2025, the company said, adding that study startup activities have started in collaboration with Worldwide Clinical Trials.
ART26.12, the lead compound in the company's fatty acid binding protein platform, is being developed as a non-opioid treatment for neuropathy, the company said.
Shares of Artelo Biosciences were up more than 3% in recent Monday trading.
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