Year: 2022

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.

Contacts: AlgoTx : contact@algotx.com. Communication: Geneviève CLIQUET Consultant –
www.algotx.com

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.