AlgoTx Announces “Last Patient Last Visit” in International Phase II Trial of ATX01 in Chemotherapy-Induced Peripheral Neuropathy
Paris, France, 24 Sept: AlgoTherapeutix (AlgoTx), a clinical stage biotechnology company developing a first-in-class therapeutic for peripheral neuropathic pain, ATX01, announced today the completion of the Last Patient Last Visit (LPLV) in its 276 patient Phase II trial known as ‘ACT (ATX01 in ChemoTherapy-induced peripheral neuropathy)’.
Conducted under the guidance of Professor Guido Cavaletti (Univ of Milano-Bicocca, Italy), ACT is an international, double-blind, placebo-controlled evaluation of ATX01’s efficacy and safety in patients suffering from CIPN, a common side effect of neurotoxic cancer treatments caused by nerve degeneration (1).
AlgoTx’s Founder, President & CEO, Stéphane Thiroloix said, “We’re delighted with the solid progress of our ACT clinical trial and are grateful to the patients, investigators and AlgoTx clinical team for their dedication in achieving this major milestone. The trial involved over 40 sites in the US, Belgium, Czechia, France, Italy, Poland and Spain, which is a significant undertaking, and commitment to making a difference, for any biotech company.”
AlgoTx’s Chief Development Officer, Philippe Picaut added, “CIPN affects two thirds of chemotherapy patients, representing a high unmet need without any approved treatments. We are enthused to see the last patient finish the study as we plan for the final development stages and hope to deliver the first approved treatment for CIPN.”
The company’s high-concentration, non-opioid ATX01 selectively targets specific nociceptive sodium channels in the peripheral nervous system involved in pain signaling. Its twice-daily local application provides sufficient concentrations to alleviate extreme pain whilst minimizing toxicity through limited systemic exposure.
Reference:
(1) “Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (ACT)”. The purpose of this clinical trial is to compare the efficacy of twice daily applications of ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating CIPN in adult cancer survivor patients. Full details here: [link]