- First patients enrolled in ACT study in Chemotherapy-Induced Peripheral Neuropathy
- IND opened and Fast Track Designation granted by FDA for Erythromelalgia
Suresnes, France, March 30th 2023.
European biotech AlgoTx, a clinical stage innovator in complex pain, today announces that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for its Phase 2 first-in-class candidate ATX01 in the treatment of erythromelalgia. Meanwhile, the first patients have been randomized into the “ATX01 for the pain of ChemoTherapy” (ACT) study in Chemotherapy-Induced Peripheral Neuropathy (CIPN). Both programs have been granted Fast Track Designation by the FDA.
AlgoTx is conducting the ACT study as part of its US / EU Phase 2 program in the indication of CIPN. The randomized, double-blind, placebo-controlled study aims to recruit 240 patients in more than 40 sites in the US, Belgium, Czech Republic, France, Italy, Poland and Spain.
Separately, FDA clearance of the IND for ATX01 in the indication of erythromelalgia opens the way for the Phase 2 “Efficacy of ATX01 Study in Erythromelalgia” (EASE) trial, a randomized, double-blind, placebo-controlled, cross-over study that will take place at the Mayo Clinic in the US and the Erlangen University Hospital in Germany. The study has also been approved by the German regulatory agency, BfArM.
Erythromelalgia is a rare neurovascular disease involving frequent episodes of swelling, redness, and often intense burning pain in the feet and/or hands of affected individuals. Episodes can be spontaneous or triggered by heat or exercise, and there is currently no cure for the condition nor any approved or consistently effective treatment available. AlgoTx has obtained an Orphan Disease Designation from both FDA and EMA to support development of ATX01 in this indication.
Dr Gabriel Fox, Chief Medical Officer of AlgoTx, commented: “This IND is further validation of our development work to date, and we are now eager to explore ATX01’s potential in this painful and distressing rare disease with the outstanding teams at the Mayo Clinic and Erlangen University Hospital.”
ATX01 is designed to inhibit pain messaging by directly targeting small sensory nerve fibers in the skin which generate and conduct pain messages from the peripheral nervous system to the spinal cord and brain. ATX01 acts locally to inhibit the nociceptive activity of voltage-gated sodium-channels Nav1.7, Nav1.8 and Nav1.9, in particular in peripheral sensory nerve fibers A∂ and C. Its systemic passage is minimal, enabling a favorable tolerance profile.
“With the ACT study in its active phase and the EASE study now on the launch pad, we look forward to bringing hope to those patients in extreme need of relief, thanks to valuable support from our CRO partner Worldwide Clinical Trials, from the investigators and most importantly from the patients entering the study” said Dr Philippe Picaut, AlgoTx’s Chief Development Officer.