Nyrada Activates First Site for Heart Attack Trial Targeting 5M Annual Procedures
Nyrada activates first hospital site in Xolatryp heart attack trial
Nyrada Inc (ASX: NYR) has activated the first hospital site for its PROTECT-MI Phase IIa clinical trial, with Nepean Hospital in NSW now actively recruiting patients to assess Xolatryp’s safety and preliminary efficacy in reducing myocardial injury in heart attack patients undergoing percutaneous coronary intervention (PCI). The activation marks completion of site governance approval, staff training, and drug delivery, meaning consenting patients attending Nepean Hospital are now eligible to participate in the trial.
The company received Human Research Ethics Committee (HREC) approval in January 2026, and this activation represents the formal launch of clinical trial operations. The trial, registered as NCT07362446 on ClinicalTrials.gov, transitions Xolatryp from regulatory planning into active patient recruitment, a tangible operational milestone for investors monitoring execution quality.
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What is ischemia-reperfusion injury and why does it matter?
When a blocked artery is reopened during PCI (angioplasty with stent implantation), the sudden return of oxygenated blood paradoxically causes irreversible damage to heart muscle cells. This phenomenon, known as ischemia-reperfusion injury, occurs due to a vicious cycle of calcium overload that triggers cell death in the heart muscle. The clinical problem is significant: approximately 5 million PCI procedures are performed globally each year (including around 50,000 in Australia), yet there are no approved therapies that directly address ischemia-reperfusion injury.
PCI is a well-established, lifesaving procedure for heart attack patients, but the reperfusion injury that follows is unavoidable using current treatment protocols. Xolatryp aims to fill this treatment gap by protecting heart tissue during the critical window when the artery is reopened. If successful, Xolatryp would be the first drug approved to mitigate ischemia-reperfusion injury, addressing an unmet need in a large, established procedural market.
How Xolatryp works to protect heart tissue
Xolatryp is a small-molecule inhibitor of calcium-permeable TRPC 3/6/7 ion channels. By limiting pathological calcium influx into heart muscle cells, Xolatryp is designed to protect against processes associated with irreversible injury, including mitochondrial dysfunction, ATP depletion, osmotic imbalance, and excess reactive oxygen species formation. These processes are known contributors to ischemia-reperfusion injury following PCI.
Preclinical cardioprotection signals
Animal model data provides the biological rationale for Phase IIa efficacy endpoints. In preclinical myocardial ischemia-reperfusion injury models, Xolatryp showed dose-dependent cardioprotection:
- 30 mg/kg over 24 hours: 86% cardioprotection, improved cardiac function, and reductions in AST, LDH, and Troponin I biomarkers.
- 9 mg/kg over 3 hours: 42% cardioprotection, 90% reduction in arrhythmias, and lower Troponin I levels.
These preclinical signals suggest that Xolatryp’s mechanism of limiting calcium overload translates into measurable reductions in heart muscle damage and cardiac complications. The dose-dependent response profile supports the rationale for the 3 mg/kg infusion dose selected for the Phase IIa trial.
Phase IIa trial design and what success looks like
The PROTECT-MI trial is a randomised, double-blind, placebo-controlled, multicentre study in Australia. The primary endpoint is safety and tolerability, including cardiac-related safety. However, the trial design incorporates multiple secondary endpoints to provide early efficacy signals even though this is primarily a safety study. The trial will enrol first-time STEMI patients undergoing primary PCI within 6 hours of symptom onset.
| Parameter | Detail |
|---|---|
| Population | First-time STEMI; primary PCI within 6 hours of symptom onset |
| Patients | 100 evaluable (50 drug, 50 placebo) |
| Intervention | IV Xolatryp 3 mg/kg over ~6 hours |
| Primary Endpoint | Safety/tolerability including cardiac-related safety |
| Exploratory Endpoints | Cardiac MRI infarct size, arrhythmias, Troponin I, PK, Day-30 PROs |
The 100-patient design is sized to generate both safety data required for regulatory progression and exploratory efficacy signals that could support partnership discussions or accelerated development pathways. Exploratory endpoints include cardiac MRI assessment of infarct size, incidence of arrhythmias of interest, serum Troponin I levels, pharmacokinetics (PK), and patient-reported outcomes (PROs) at Day 30.
Phase I data supports clinical rationale
Nyrada’s completed Phase I trial in healthy volunteers validated the safety profile and pharmacokinetic properties of Xolatryp prior to initiating Phase IIa. The trial enrolled 48 participants across six cohorts (36 active, 12 placebo) and met its primary endpoint, with all doses shown to be safe and well-tolerated. There were no dose-limiting or dose-related safety issues identified.
Pharmacokinetics was linear and predictable, with therapeutic levels reached within 10 minutes post start-of-infusion. This rapid onset is particularly relevant for the emergency heart attack setting, where time to treatment is critical. The Phase I results de-risked the transition to patient populations and confirmed the dosing regimen selected for PROTECT-MI.
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What investors should watch for next
As further sites are activated, Nyrada will update the trial’s ClinicalTrials.gov record. Investors should monitor recruitment pace and subsequent site activations as leading indicators of trial execution quality. The coordinating principal investigator for PROTECT-MI is Professor William Chan, a cardiologist with expertise in interventional cardiology and heart attack management.
Successful safety and efficacy signals from PROTECT-MI could position Xolatryp as a first-in-class therapy for a large global market. With 5 million PCI procedures performed annually worldwide and no approved treatments that directly target ischemia-reperfusion injury, Xolatryp addresses a significant commercial opportunity if clinical data supports the preclinical cardioprotection signals.
The company was authorised to release this announcement by Non-Executive Chair John Moore on behalf of the Board. Site activation confirms operational readiness and transitions the PROTECT-MI trial from regulatory planning into active clinical operations, a tangible milestone that de-risks the execution pathway for this Phase IIa programme.
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