Nexalis Therapeutics (ASX:NX1) announced a clinical breakthrough with the screening of the first patient in its Phase 2 clinical trial for IRX-211.
The investigative treatment is designed to combat breakthrough cancer pain, a sudden and intense flare of pain that occurs despite stable background opioid therapy.
The milestone marks the transition of IRX-211 from healthy volunteer testing into controlled clinical evaluation within its intended patient population.
The multicentre study is structured as a randomised, double-blind, placebo-controlled cross-over trial.
It begins with 'Part A', an open-label titration phase where adult patients self-titrate the medication to identify an individualised effective dose.
'Part B' follows as a rigorous cross-over evaluation, where at least 78 of the planned 156 recruits will treat multiple BTcP episodes with either IRX-211 or a placebo.
The design allows for a direct within-patient comparison of efficacy and safety, providing high-quality data for future regulatory discussions.
Nexalis is eyeing a substantial market opportunity, with the global cancer pain sector estimated to reach approximately US$11 billion by 2028.
Following a successful Phase 1 programme that demonstrated an excellent safety profile and rapid systemic exposure, the company remains positioned for value-driving data.
The trial not only validates the clinical potential of IRX-211 but also strengthens Nexalis’s standing for future global partnering opportunities in the oncology and palliative care space.
At the time of reporting, Nexalis Therapeutics’ share price was $0.023.