Nyrada (ASX:NYR) says its PROTECT MI Phase 2a study of Xolatryp remains on track for completion in calendar 2027 and is moving through the staged rollout typical of first-in-patient cardiovascular studies.
The company has reported that since the activation of the first clinical trial site, close to 20 patients have been pre-screened, but "No patients have yet been enrolled. This is not a significant deviation from the trial plan." Most pre-screened patients did not proceed because they arrived outside pharmacy operating hours or fell outside protocol eligibility, most commonly the upper age limit of 75 years.
To capture those missed patients and accelerate recruitment, Nyrada said it plans to move selected sites to store Xolatryp in the cardiac catheterisation laboratory, enabling 24-hour recruitment once initial in-hours phases are complete. The company expects recruitment to pick up from the third quarter of the current calendar year as additional sites activate.
Two further sites are nearing Research Governance Office approval, and Royal Perth Hospital has been selected to participate, while Royal Hobart Hospital withdrew due to local resourcing constraints.
Nyrada says it will monitor site performance and retain the flexibility to activate additional sites or discontinue underperforming centres to focus resources on the strongest recruiters. The trial is also being expanded to discussions with several additional hospitals, including sites in New Zealand.
The company said an Investigational New Drug application is targeted for submission to the US Food and Drug Administration in the second half of 2026.
Nyrada describes the Phase 2a study as a randomised double blind placebo controlled multicentre trial in first time STEMI patients undergoing primary PCI within six hours of symptom onset. The plan is for approximately 100 evaluable patients randomised one-to-one to Xolatryp or placebo, with an intravenous infusion of Xolatryp at 3 mg per kilogram over about six hours. Safety is the primary endpoint with multiple exploratory efficacy measures, including cardiac MRI infarct size, arrhythmias, Troponin I and day 30 patient-reported outcomes.
The company highlights encouraging preclinical and Phase I findings. In animal models, Xolatryp "showed 86% cardioprotection with improved cardiac function and reductions in biomarkers when dosed at 30 mg/kg over 24 hours" and "42% cardioprotection, 90% reduction in arrhythmias, and lower Troponin I levels when dosed at 9 mg/kg over 3 hours."