AlgoTherapeutix (AlgoTx) has commenced its Phase II clinical trial of ATX01 (topical amitriptyline) for pain relief in chemotherapy-induced peripheral neuropathy (CIPN) in adult patients.
The multicentre, placebo-controlled, international, randomised, double-blind trial will assess the safety and efficacy of two concentrations of ATX01.
It will enrol 240 adult subjects with CIPN caused by platinum salts or taxanes in more than 40 centres in Europe and the US.
The company anticipates reporting preliminary data from the trial in early 2024.
The Phase II trial plan for ATX01 recently obtained Investigational New Drug (IND) application clearance from the Food and Drug Administration (FDA), as well as from European countries linked to the trial.
A new, topical formulation of amitriptyline, ATX01 has a non-systemic mode of action locally.
It hinders pain signalling in the nerve fibres of the skin while reducing systemic penetration to evade undesirable toxicity.
In June last year, the FDA granted Fast-Track designation for ATX01 in CIPN.
AlgoTx founder and CEO Stéphane Thiroloix said: “We are excited to begin the ATX01 Phase II trial in CIPN.
“With meaningful efficacy data, we could come a significant step closer to offering millions of patients relief from their debilitating pain.”
According to data from the Phase I clinical trial, ATX01 was found to have favourable local and systemic tolerance in healthy subjects, as well as reduced systemic passage.
AlgoTx chief development officer Philippe Picaut said: “Chemotherapy-induced neuropathic pain affects over half of chemotherapy patients and has no approved treatment.
“Following successful pre-clinical and Phase I clinical development, we are eager to confirm our efficacy hypothesis in patients in need of pain relief.”