AlgoTx Completes Phase II Trial of ATX01 for Chemotherapy-Induced Neuropathy

AlgoTherapeutix (AlgoTx), a clinical-stage biotech firm based in PARIS, announced the completion of the Last Patient Last Visit (LPLV) in its Phase II clinical trial for ATX01, a pioneering treatment for peripheral neuropathic pain, specifically chemotherapy-induced peripheral neuropathy (CIPN). The trial, known as 'ACT (ATX01 in ChemoTherapy-induced peripheral neuropathy)', involved 276 patients and was overseen by Professor Guido Cavaletti from the University of Milano-Bicocca, Italy. This rigorous international study was a double-blind, placebo-controlled evaluation that aimed to determine the efficacy and safety of ATX01 in managing CIPN, a common and debilitating side effect of neurotoxic cancer treatments.

Stéphane Thiroloix, the Founder, President, and CEO of AlgoTx, expressed his satisfaction with the trial's progress, emphasizing the collaborative efforts of the patients, investigators, and the clinical team. Thiroloix acknowledged the extensive scope of the trial, which spanned over 40 sites across the US, Belgium, Czechia, France, Italy, Poland, and Spain, highlighting the dedication required to reach such a significant milestone.

Philippe Picaut, AlgoTx’s Chief Development Officer, highlighted the severe impact of CIPN, which affects approximately two-thirds of chemotherapy patients and currently lacks approved treatments. Picaut underscored the importance of any advancements in this field and expressed eagerness to share the trial data and move forward with the next phase of development.

ATX01 is a high-concentration, non-opioid topical formulation that selectively targets specific nociceptive sodium channels in the peripheral nervous system, which are involved in pain signaling. The formulation is designed for twice-daily local application, delivering sufficient concentrations to alleviate severe pain while minimizing systemic toxicity.

The clinical trial, referenced as “Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (ACT)”, focused on comparing the efficacy of twice-daily applications of ATX01 in 10% and 15% concentrations against a placebo over a 12-week treatment period in adult cancer survivors suffering from CIPN.

AlgoTherapeutix has effectively completed recruitment for this international Phase II trial and anticipates providing the final data readout by early 2025. The company is also planning to expedite a Phase 3 trial based on these findings.

Founded with a vision to address the unmet needs in peripheral neuropathic pain, AlgoTherapeutix boasts a leadership team experienced in bringing global products to market successfully. The company has secured significant funding, raising EUR 20 million in a Series B round in 2023, contributing to a total of EUR 35 million raised to date. The Series B round was led by Relyens Innovation Santé / Turenne Capital, and other investors include UI Investissement and angel investors. Previous funding came from Bpifrance through the Innobio 2 fund and Omnes Capital.

In recognition of its commitment to environmental, social, and governance (ESG) initiatives, AlgoTherapeutix was awarded France Biotech’s prestigious ESG HealthTech Trophy in 2023. The company continues to build on its success and remains dedicated to making significant strides in the treatment of peripheral neuropathic pain.