AlgoTherapeutix Announces Initiation of Global Phase 2 Clinical Trial of ATX01 for the Relief of Pain in Chemotherapy-induced Peripheral Neuropathy in Adults

SURESNES, France--(BUSINESS WIRE)--AlgoTx, a biotechnology company dedicated to developing treatments for complex pain, announced today the initiation of its Phase 2 global clinical trial in Chemotherapy-Induced Peripheral Neuropathy in adult patients. The trial will evaluate the efficacy and safety of two concentrations of ATX01 (proprietary topical amitriptyline).

ATX01 received Fast-Track designation from the US Food & Drug Administration last June for its development in CIPN. “We are excited to begin the ATX01 Phase 2 trial in CIPN”, said Stéphane Thiroloix, Founder and CEO of AlgoTx. “With meaningful efficacy data, we could come a significant step closer to offering millions of patients relief from their debilitating pain.”

The multicenter, randomized, double-blind, placebo-controlled trial seeks to enroll 240 adult patients with CIPN caused by platinum salts or taxanes in over 40 centers in the US and Europe. Initial results are expected in early 2024.

“Chemotherapy-induced neuropathic pain affects over half of chemotherapy patients and has no approved treatment,” commented Philippe Picaut, Chief Development Officer of AlgoTx. “Following successful pre-clinical and phase 1 clinical development, we are eager to confirm our efficacy hypothesis in patients in need of pain relief.”

About ATX01
ATX01 is a novel, patented, topical formulation of amitriptyline. Its non-systemic mode of action locally inhibits pain signaling in the skin’s nerve fibers whilst minimizing systemic penetration, thus avoiding unwanted toxicity.

Phase 1 clinical development showed favorable local and systemic tolerance in healthy volunteers and low systemic passage. The planned Phase 2 development will establish clinical efficacy in patients with chemotherapy-induced peripheral neuropathy.

The ATX01 Phase 2 plan recently gained clearance from FDA (IND) and from European countries involved in the trial, and FDA granted ATX01 a Fast-Track designation for its development in CIPN. ATX01 also benefits from Orphan Drug Designation for its development in erythromelalgia in both the US and the EU.

About AlgoTx
AlgoTx is a clinical-stage European biotech focused on developing innovative solutions for complex pain, with initial programs focusing on chemotherapy-induced neuropathic pain and erythromelalgia. AlgoTx has established partnerships with leading CRO’s and institutions to support the development of its programs.