• Phase IIa trial planned for Xolatryp targeting patients with acute myocardial infarction
• Trial to assess safety and explore efficacy in STEMI patients undergoing PCI
• Indicative study design incorporates 150 patients in a randomised, double-blind, placebo-controlled trial

Nyrada Inc (ASX:NYR), a clinical stage drug discovery and development company, announced its intention to progress Xolatryp into a Phase IIa clinical trial for the treatment of acute myocardial infarction (AMI). The Phase IIa trial design seeks to evaluate Xolatryp as a first-in-class intravenous therapy to limit heart muscle damage and prevent arrhythmias during ischemia and after reperfusion in patients with ST-Elevation Myocardial Infarction (STEMI) that undergo Percutaneous Coronary Intervention (PCI). The indicative Phase IIa trial design envisages the enrolment of up to 150 STEMI patients in Australia, evaluating two dosage levels of Xolatryp with infusion durations of up to six hours. The trial is expected to commence in the first quarter of calendar 2026, pending completion of the Phase I study and approval by the Human Research Ethics Committee (HREC). The primary endpoint of the trial will be safety, with secondary endpoints including indications of functional cardiac outcomes. Nyrada's Phase I trial of Xolatryp is nearing completion, with the final cohort participants dosed and discharged with no adverse safety signals reported. Combined with strong preclinical evidence for cardioprotection, this provides the company with confidence to commit to the Phase IIa trial.

Nyrada estimates that approximately 950,000 PCIs are performed annually in the US, and the PCI market size was US$11.7 billion in 2024 and is expected to grow at a CAGR of 10.03%.