AlgoTx Receives Regulatory Approval to Initiate Clinical Development of ATX01

France-based biotechnology company AlgoTx, the developer of an innovative topical treatment for chemotherapy-induced peripheral neuropathy (CIPN), announced today it has received approval from the ethics committee and the regulatory authority in the Czech Republic to initiate a Phase 1 clinical trial with ATX01. The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021.

I am thrilled by the entry of ATX01 in clinical development as it represents a great step forward towards providing CIPN patients with a response to the crippling pain they endure.

Stéphane Thiroloix, Founder & CEO of AlgoTx


AlgoTx recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. Given a positive outcome of the approved Phase 1 study, the company intends to initiate Phase 2 by the end of 2021.

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

Over the last two years, AlgoTx took ATX01 from exploratory prototype to final formulation, established its pharmacological profile, conducted a full pre-clinical toxicology package, and scaled-up manufacturing to enable clinical supply production. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia.

A recent publication in the “Journal of Pain” describes the exploratory pharmacological impact of high-dose topical amitriptyline in CIPN patients along with the mechanism of action supporting its activity (