Nyrada to Dose 200 Patients in Phase IIa Xolatryp Heart Attack Study
Nyrada has secured ethics approval to begin a pivotal Phase IIa trial of its drug Xolatryp, targeting heart attack damage. Patient dosing is set to start in March 2026 across multiple Australian hospitals.
- Human Research Ethics Committee approval granted for Phase IIa trial
- Trial to assess safety and preliminary efficacy of Xolatryp in heart attack patients
- Approximately 200 patients to be enrolled in a randomized, placebo-controlled study
- Patient recruitment expected to begin March 2026 at up to 10 Australian hospitals
- Plans for potential international trial expansion and FDA Investigational New Drug application
Ethics Approval Unlocks Next Phase
Biotech company Nyrada Inc. has taken a significant step forward with the Human Research Ethics Committee (HREC) granting approval to commence its Phase IIa clinical trial of Xolatryp®. This milestone allows the company to initiate patient recruitment and dosing, expected to start in March 2026. The trial will focus on patients suffering from ST-Elevation Myocardial Infarction (STEMI), a severe form of heart attack, undergoing primary percutaneous coronary intervention (PCI).
Trial Design and Objectives
The study is designed as a randomized, double-blind, placebo-controlled, multicentre trial involving approximately 200 patients across up to ten Australian hospitals. It aims primarily to evaluate the safety and tolerability of Xolatryp, a novel small molecule that inhibits calcium ion influx through TRPC channels, potentially reducing the damage caused by ischemia reperfusion injury during heart attacks.
Secondary endpoints include assessing cardiac function, infarct size via MRI, biomarker levels such as troponin I, and the incidence of arrhythmias. These measures will provide early signals of efficacy, informing the drug’s potential to improve outcomes for heart attack patients.
Strategic Expansion and Regulatory Pathways
While the initial trial is confined to Australia, Nyrada has outlined plans to expand recruitment internationally to countries with aligned regulatory frameworks, including New Zealand, Singapore, and Canada. The company also intends to submit an Investigational New Drug application to the US Food & Drug Administration, paving the way for potential US trial sites.
This strategic approach reflects Nyrada’s ambition to position Xolatryp as a globally relevant cardioprotective therapy, addressing a significant unmet need in acute myocardial infarction treatment.
Looking Ahead
With patient recruitment expected to span 9 to 18 months depending on enrolment rates, the trial’s progress will be closely watched by investors and clinicians alike. The outcomes could influence the future of heart attack management, particularly if Xolatryp demonstrates a favourable safety profile alongside meaningful efficacy signals.
As the trial unfolds, Nyrada’s ability to navigate regulatory requirements and accelerate patient enrolment will be critical to maintaining momentum in this competitive therapeutic area.
Bottom Line?
Nyrada’s Phase IIa trial launch marks a promising step in heart attack treatment innovation, but patient recruitment and trial outcomes will be decisive.
Questions in the middle?
- How quickly will Nyrada be able to recruit the targeted 200 patients across Australian sites?
- What early efficacy signals might emerge from secondary endpoints like infarct size and biomarker levels?
- How soon could international expansion and FDA approval processes impact the trial’s scope?
