1 June 2022
FDA Grants AlgoTx IND Clearance for Phase 2 Trial of ATX01 in Chemotherapy-Induced Peripheral Neuropathy

European biotech AlgoTx, an innovator in complex pain therapy, today announces the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug Application (IND) for Phase 2 candidate ATX01 in the treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN).

Over half of cancer patients treated with chemotherapy develop CIPN and experience sensory symptoms and pain in the feet and hands including loss of sensitivity, tingling, cold allodynia, intense burning and shooting pain that can persist for months to years after treatment. CIPN is a leading cause of modification or interruption of chemotherapy. To this date, no therapeutic approach has offered a satisfactory response for patients and their caregivers, oncologists, neurologists and pain specialists.

ATX01 enjoys solid intellectual property including its patented topical formulation of amitriptyline 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 spine and brain. Indeed ATX01’s breakthrough pre-clinical investigation evidenced the anti-nociceptive activity of amitriptyline on voltage-gated sodium-channels Nav1.7, Nav1.8 and Nav1.9 and on peripheral sensory nerve fibers A∂ and C. ATX01’s Phase 1 program established safety in healthy volunteers and limited systemic passage designed to avoid the systemic side-effects of oral and injectable compounds.

Philippe Picaut, Chief Development Officer, commented: “This IND is a validation of our development work to date, and we are now eager to work alongside a large team of enthusiastic investigators in the US and Europe who share our goal of bringing relief to CIPN patients.”

FDA’s IND clearance opens the way for the planned Phase 2 study, a multi-center, double-blind, randomized, placebo-controlled study of ATX01 in the pain of CIPN in adult cancer survivors. The study aims to establish ATX01’s efficacy and safety in CIPN patients and will be conducted in the US and Europe.

“This IND is a major milestone for CIPN patients and for AlgoTx. In an indication without therapeutic solutions, ATX01’s highly differentiated mode of action has the potential to finally bring relief to patients with CIPN,” says Stéphane Thiroloix, AlgoTx’s founder and CEO.

About AlgoTx : AlgoTx is a European biotech founded in 2018 to develop innovative solutions for complex pain, whose Series A funding was led by Bpifrance and Omnes Capital. ATX01 is entering Phase 2 in painful peripheral neuropathy.