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 commend 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. Any progress in this field is therefore very gratifying. We look forward to sharing the ACT data and progressing to the next stage.”

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]

About AlgoTherapeutix (AlgoTx)

AlgoTherapeutix (AlgoTx) is a clinical stage biotechnology company developing a targeted, first in class therapeutic for peripheral neuropathic pain. Its lead asset, ATX01, is a proprietary topical formulation of amitriptyline for use in chemotherapy-induced peripheral neuropathy (CIPN), an area of high unmet need associated with unbearable pain in patients’ extremities and for which there is currently no viable treatment options.

ATX01 targets the signaling pathways involved in the regulation of pain by inhibiting specific nociceptive sodium channel receptors. Its topical administration provides targeted relief from the excruciating pain in patients’ extremities from CIPN, which is caused by nerve degeneration and is a common side effect of cancer treatment, occurring in 68% of patients. ATX01 was granted FDA fast track development status in CIPN.

The company has completed recruitment into an international Phase II clinical trial of 276 patients with CIPN (the ‘ACT’ study). This trial is due to provide its final data read early in 2025, and the company is making plans to expedite a Phase 3 trial.

The company has seasoned leadership, with experience of bringing global products successfully to market, and is backed by an international board. AlgoTx raised a Series B round of EUR 20 million in 2023 and has raised EUR 35 million to date. AlgoTx has a consortium of investors including Relyens Innovation Santé / Turenne Capital, who led the Series B fund raise, along with UI Investissement, and angel investors. Historical investors include Bpifrance through its Innobio 2 fund and Omnes Capital.

In 2023, the company won France Biotech’s prestigious ESG HealthTech Trophy in recognition of its early commitment to ESG initiatives.