Our lead asset, ATX01, targets the signaling pathways involved in the regulation of pain by inhibiting specific nociceptive sodium channels.
It has been designed to provide targeted relief from excruciating pain in the feet and hands of patients suffering from Chemotherapy-Induced Peripheral Neuropathy (CIPN), a common and painful attack of cancer chemotherapy on peripheral nerve fibers.
AlgoTx’s ATX01 product has wide potential applicability beyond CIPN, in other diseases where peripheral neuropathic pain is a major issue.
By applying the ATX01 hydrogel to the skin, the active ingredient is locally delivered to the nerve endings where pain signals originate and propagate alongside the neurons to the central nervous system. This method of application is especially relevant to CIPN which involves localized pain. Topical administration also minimizes systemic toxicity and drug interactions through limited systemic exposure, which is particularly important in patients exposed to chemotherapy.
Unmet Need
Our lead asset, ATX01, has been designed to provide targeted relief in CIPN.
CIPN occurs in 68% of patients on chemotherapy and results from chemotherapy causing damage to the patient’s pain-signalling nerve fibers. It can be crippling, with chronic burning and stabbing pains in the feet and/or hands, as well as allodynia – feeling pain from actions that are not normally painful.
CIPN pain significantly influences quality of life and prevents patients from performing their daily personal and professional activities. Furthermore, it can be strong enough to cause cessation or alterations of cancer treatments, which in turn
impact cancer-related morbidity and mortality.1&2
Around 30% of patients will still be suffering CIPN a year or more after finishing chemotherapy. Neither preventative nor
symptomatic therapies have shown significant clinical efficacy.3 Treating the pain of CIPN represents a considerable unmet
medical need.4
ATX01 was granted FDA fast track development status in CIPN.
AlgoTx completed the Phase 2 clinical trial (the “ACT” study) which included 276 CIPN patients in the US and Europe and yielded meaningful insights for further development. The company is making plans to expedite further development and registration.
For details of AlgoTx’s expanded access policy for CIPN, click here:
Unmet Need
AlgoTx was granted FDA and EMA Orphan Drug Designation for ATX01’s development in erythromelalgia.
In 2024, AlgoTx conducted a double-blind, cross-over study in adult erythromelalgia patients at the Mayo Clinic (Rochester, US) and Erlangen University Hospital (Germany), which did not show superiority of ATX01 over placebo in this indication. In view of the patient heterogeneity inherent to this disease, and of the resulting complexity of producing clear outcomes in clinical trials of erythromelalgia, AlgoTx decided not to further the development of ATX01 in this indication.
Following the completion of the CIPN program, AlgoTx plans to develop ATX01 in additional indications where peripheral neuropathic pain is a major issue, such as Painful Diabetic Peripheral Neuropathy and Phantom Limb Pain (Pre-IND).