Nyrada (ASX:NYR) is progressing steadily toward the next stage of clinical development for its lead cardioprotective drug candidate, Xolatryp, with the company confirming that its Phase 2a trial remains on track to commence in March 2026.
The clinical-stage biotechnology company, which specialises in developing small-molecule inhibitors of TRPC ion channels, has now submitted its Human Research Ethics Committee (HREC) application and expects a final decision by February 2026. Subject to approval, patient dosing will commence soon after.
The trial will assess the safety, tolerability, and preliminary efficacy of Xolatryp in patients experiencing ST-elevation myocardial infarction (STEMI) who undergo primary Percutaneous Coronary Intervention (PCI).
STEMI remains one of the most severe and time-critical forms of heart attack. PCI, commonly known as angioplasty and stenting, is the standard of care and is performed hundreds of thousands of times each year in the US and Europe, as well as around 50,000 times annually in Australia. Despite the effectiveness of PCI in reopening blocked arteries, restoring blood flow can itself trigger myocardial ischemia-reperfusion injury, a damaging physiological process for which there is currently no approved therapy. Xolatryp aims to reduce this injury by inhibiting pathological calcium influx through TRPC 3/6/7 channels, thereby protecting mitochondrial function during acute myocardial infarction.
The upcoming Phase 2a study will be a randomised, double-blind, placebo-controlled, multicentre trial involving approximately 200 patients. Each participant will be assigned to receive either Xolatryp or a placebo in a 1:1 ratio, with treatment administered intravenously in patients presenting within six hours of symptom onset.
Up to ten Australian hospitals with dedicated coronary care units will participate, and Nyrada may expand to New Zealand, Singapore or Canada if recruitment proceeds more slowly than anticipated. The company also plans to file an Investigational New Drug (IND) application with the US Food and Drug Administration to allow potential expansion of the trial to American centres.
Patients confirmed with STEMI will undergo a series of safety assessments and exploratory efficacy evaluations following treatment. Those with complete or near-complete coronary artery occlusion will be invited to undergo cardiac MRI scans to assess infarct size, which is a key secondary measure of Xolatryp’s cardioprotective potential. Additional endpoints will include arrhythmia incidence, serum troponin I levels, pharmacokinetics, and patient-reported outcomes at Day 30. Safety will be evaluated in all treated patients.
To support the study, Nyrada has appointed Professor William Chan, Head of Cardiac Catheterisation Laboratories at Western Health in Melbourne, as Coordinating Principal Investigator. The company has also engaged specialist clinical CRO Accelagen to manage trial operations. Manufacturing of Xolatryp is underway, with the product expected to be ready in January 2026.
The company has already completed a Phase I trial demonstrating Xolatryp’s safety, tolerability and pharmacokinetic profile in healthy volunteers. The upcoming study will provide the first data on the drug’s performance in patients experiencing an acute cardiac event.