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 (https://doi.org/10.1016/j.jpain.2020.11.002)