Nexalis Therapeutics Ltd (ASX: NX1), an Australian clinical-stage drug development company focused on rapid-onset therapies for pain management and mental health, has announced a significant clinical milestone with the screening of the first patient in its Phase 2 trial for IRX-211. This investigational drug is being evaluated for the treatment of Breakthrough Cancer Pain (BTcP), marking a crucial advancement in the development program and a transition into controlled clinical evaluation within its intended patient population.
The Phase 2 study is a multicentre, randomised, double-blind, placebo-controlled, cross-over trial designed to assess the efficacy, safety, and patient-reported outcomes of IRX-211. The trial will enrol adult cancer patients who experience BTcP despite stable background opioid therapy. The study consists of two parts: an open-label titration phase (Part A) to identify an individualised effective dose, followed by a double-blind cross-over phase (Part B) for within-patient comparison against placebo. The trial aims to recruit approximately 156 patients, building on a Phase 1 program in healthy volunteers that demonstrated an excellent safety profile, rapid systemic exposure, and consistent pharmacokinetics.
Breakthrough Cancer Pain represents a high-burden and often inadequately addressed condition within oncology supportive care. The global cancer pain market is estimated to reach approximately US$11 billion by 2028. IRX-211 is designed as a proprietary inhaled therapy, aiming to provide rapid, predictable, and patient-controlled relief, aligning with the critical needs of BTcP patients. Nexalis Therapeutics CEO, Darryl Davies, stated that screening the first patient signifies the beginning of generating efficacy data in patients, addressing a substantial treatment gap due to the limitations of current opioid options and the rapid onset of pain episodes. The company anticipates this study will establish a strong foundation for demonstrating clinical benefit and potential future partnering opportunities.
