Xolatryp Phase IIa Trial to Enroll 150 STEMI Patients in 2026

Nyrada's Clinical Progress

Nyrada Inc. (ASX, NYR) has announced a significant step forward in the development of its lead drug candidate, Xolatryp™, with plans to initiate a Phase IIa clinical trial targeting patients suffering from acute myocardial infarction (AMI). This trial will focus on those experiencing ST-Elevation Myocardial Infarction (STEMI) who undergo Percutaneous Coronary Intervention (PCI), a common procedure to restore blood flow after a heart attack.

The Phase IIa study is designed as a randomized, double-blind, placebo-controlled trial involving approximately 150 patients across Australia. It aims primarily to assess the safety of Xolatryp when administered intravenously over six hours, while also exploring early signs of efficacy in limiting heart muscle damage and preventing arrhythmias caused by ischemia and reperfusion injury.

Addressing a Critical Unmet Need

Reperfusion injury, the tissue damage caused when blood supply returns to the heart after ischemia, remains a major challenge in cardiology with no approved therapies directly targeting this condition. Xolatryp’s mechanism, involving inhibition of TRPC ion channels, offers a novel approach to protect heart tissue during this vulnerable period. Preclinical studies have demonstrated substantial cardioprotective effects, including an 86% reduction in damage with a six-hour treatment and significant improvements in heart function and structure.

These promising results, combined with the near completion of a Phase I trial showing no adverse safety signals, have given Nyrada the confidence to advance Xolatryp into this next clinical phase. The company expects to commence the Phase IIa trial in the first quarter of 2026, pending final Phase I data and ethics committee approval.

Strategic Focus and Market Potential

While Xolatryp has shown potential in other indications such as stroke and traumatic brain injury, Nyrada has strategically prioritized cardioprotection due to the strength of its cardiac data and the significant market opportunity. With nearly one million PCIs performed annually in the US alone and a PCI market valued at US$11.7 billion in 2024, the potential commercial impact is substantial.

Nyrada will continue to advance its other programs and seek non-dilutive funding to support broader development efforts. The company is also refining the Phase IIa trial design in collaboration with leading cardiologists to optimize clinical outcomes and regulatory compliance.

Looking Ahead

Completion of the Phase I trial dosing phase marks a key milestone, with final safety data expected in the September quarter of 2025. The upcoming Phase IIa trial will be closely watched by investors and clinicians alike as it represents a critical test of Xolatryp’s potential to transform treatment for heart attack patients by addressing a long-standing therapeutic gap.