ATX01, a new topical treatment for chemotherapy-induced peripheral neuropathy, will be investigated in a phase 2 trial.
Researchers recently initiated a phase 2 clinical trial evaluating ATX01 (topical amitriptyline) for adults with chemotherapy-induced peripheral neuropathy (CIPN), according to AlgoTx, the manufacturer of the drug.
The trial — which will be conducted in more than 40 centers in the United States and Europe —will include approximately 240 patients with platinum-based or taxane-related CIPN. Participating patients will be randomly assigned to receive either ATX01 (at one of the two concentrations being studied) or a placebo.
"Chemotherapy-induced neuropathic pain affects over half of chemotherapy patients and has no approved treatment," said Philippe Picaut, chief development officer of AlgoTx, in a company-issued press release. "Following successful pre-clinical and phase 1 clinical development, we are eager to confirm our efficacy hypothesis in patients in need of pain relief."
CIPN is a common side effect from chemotherapy treatments, which can manifest as numbness, tingling and/or pain in patients’ hands and feet. The condition can be long-lasting and does not currently have a cure, though in addition to drugs like ATX01, researchers are also investigating strategies such as cold therapy (similar to that used to prevent hair loss) to mitigate the severity of CIPN.
ATX01 is a topical formulation (applied directly to the skin) of amitriptyline, a drug that is currently being used to treat depression and nerve pain. It stops pain signaling in the skin’s nerve fibers, and when applied topically, minimizes the entrance into the body, thus avoiding unwanted side effects, according to AlgoTx.
A phase 1 study of ATX01 showed that it was well-tolerated in healthy volunteers. As such, the Food and Drug Administration (FDA) granted it a fast-track designation, which helps to speed up the review and development of the agent.
"With meaningful efficacy data, we could come a significant step closer to offering millions of patients relief from their debilitating pain,” Stéphane Thiroloix, founder and CEO of AlgoTx, said in the release.
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