Nyrada Inc. (ASX:NYR), a clinical-stage biotechnology company focused on developing Transient Receptor Potential Canonical (TRPC) ion channel inhibitors to treat a range of medical conditions, has announced it received Human Research Ethics Committee (HREC) approval to begin its Phase IIa clinical trial of Xolatryp in treating myocardial ischemia reperfusion injury. The trial will assess the safety and preliminary efficacy of Xolatryp in patients who have suffered a heart attack. First patient dosing is anticipated to commence in March 2026.
The Phase IIa trial is designed as a randomised, double-blind, placebo-controlled, multicentre study. It will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Xolatryp in both male and female patients not of childbearing potential who are presenting with a heart attack and undergoing primary percutaneous coronary intervention (PCI) or angioplasty with stenting. Approximately 200 patients will be dosed in the 1:1 drug to placebo trial.
While the trial’s primary endpoint is safety, secondary efficacy signals will also be evaluated. These include cardiac function, the extent of cardiac injury, biomarkers like troponin I levels, and the incidence of arrhythmias of interest. HREC approval now allows Nyrada to begin establishing trial sites across Australia, with each participating hospital also required to conduct its own Research Governance Office (RGO) review prior to opening as a trial site.
Patient recruitment rates will be a key factor in determining the duration of the trial, which is expected to conclude within 9 to 18 months from the first patient being dosed. Nyrada’s study plan incorporates the flexibility to expand to additional hospitals both in Australia and internationally, and the company intends to submit an Investigational New Drug (IND) application to the US Food & Drug Administration (FDA), paving the way for potential expansion into the United States.
