• Nyrada receives HREC approval to initiate Phase IIa clinical trial
• Trial will evaluate safety and efficacy of Xolatryp in treating myocardial ischemia reperfusion injury
• First patient dosing expected in March 2026

Nyrada Inc. (ASX:NYR), a clinical-stage biotechnology company, has announced that it has received HREC approval to commence its Phase IIa clinical trial of Xolatryp in myocardial ischemia reperfusion injury. The trial will evaluate the safety and preliminary efficacy of Xolatryp in treating myocardial ischemia reperfusion injury in patients suffering a heart attack. The trial is a randomised, double-blind, placebo-controlled, multicentre study that will enroll approximately 200 patients. Although safety is the primary endpoint, multiple secondary efficacy signals will also be evaluated, including cardiac function, extent of cardiac injury, biomarkers, and the incidence of arrhythmias. Patient recruitment and dosing is expected to commence in March 2026. Xolatryp, previously called NYR-BI03, is a small molecule therapy that inhibits calcium ion influx via TRPC 3/6/7 channels, helping to protect mitochondrial function and reduce ischemia reperfusion injury associated with acute myocardial infarction.

Nyrada plans to submit an Investigational New Drug (IND) application to the US FDA, allowing for the option to expand the trial into the US. The company also intends to explore potential avenues for broadening the trial's reach, such as New Zealand, Singapore, and Canada, subject to well-aligned regulatory frameworks.