Nyrada Launches Phase IIa Xolatryp Trial After Ethics Approval, Eyes March Recruitment
Nyrada Inc. has secured ethics approval to launch a Phase IIa clinical trial for its heart attack drug Xolatryp®, with patient recruitment set for March 2026. The company maintains a solid cash position of AU$7.12 million as it expands its research into oncology.
- Human Research Ethics Committee approval received for Phase IIa trial
- Trial to assess safety and preliminary efficacy in heart attack patients
- Patient recruitment expected to start March 2026
- AU$7.12 million cash balance as of December 2025
- Preclinical oncology studies initiated; AU$2.16 million R&D tax rebate expected
Ethics Approval Marks Key Milestone for Xolatryp
Clinical-stage biotech company Nyrada Inc. has achieved a significant regulatory milestone with the Human Research Ethics Committee (HREC) granting approval to commence its Phase IIa clinical trial of Xolatryp®. This trial will focus on patients who have suffered a heart attack and are undergoing angioplasty with stenting, a procedure known as percutaneous coronary intervention (PCI).
The trial’s primary goal is to evaluate the safety profile of Xolatryp, a small molecule designed to inhibit calcium ion influx through TRPC channels, thereby protecting cardiac tissue from ischemia reperfusion injury. Secondary endpoints will explore preliminary efficacy measures such as cardiac function and biomarker levels, including troponin I, a key indicator of heart muscle damage.
Recruitment and Trial Oversight
Patient recruitment is anticipated to begin in March 2026, with the study designed as a randomised, double-blind, placebo-controlled trial to ensure robust data integrity. Professor William Chan has been appointed as the Coordinating Principal Investigator, while Accelagen will serve as the Contract Research Organisation overseeing trial operations. Nyrada has committed to providing periodic updates on recruitment progress and safety assessments conducted by the Safety Review Committee.
Expanding Research Horizons and Financial Health
Beyond cardiology, Nyrada has initiated preclinical animal studies to evaluate Xolatryp’s potential in oncology indications, signalling a strategic expansion of its therapeutic scope. Financially, the company reported a cash balance of AU$7.12 million at the end of December 2025, down slightly from AU$7.92 million the previous quarter but bolstered by director participation in capital raises and option exercises.
Additionally, Nyrada expects to receive an R&D tax rebate of approximately AU$2.16 million for the 2025 financial year, providing further financial cushioning. The company also secured a trademark for Xolatryp covering medicinal and health services, reinforcing its intellectual property position.
Looking Ahead
While the Phase IIa trial’s efficacy data will only be available after study completion, the company’s methodical approach and solid funding position set a promising stage for upcoming clinical milestones. Investors and observers will be watching closely as recruitment unfolds and safety data emerges, alongside developments in the oncology program.
Bottom Line?
Nyrada’s clinical and financial progress positions it well for upcoming trial milestones and potential expansion into oncology.
Questions in the middle?
- How quickly will patient recruitment progress once the trial starts?
- What preliminary safety signals will emerge from the Phase IIa trial?
- How might the oncology preclinical studies influence Nyrada’s development pipeline?
