Nyrada reports successful completion of five cohorts in its Phase I trial of Xolatryp with no safety concerns, alongside compelling preclinical neuro- and cardioprotective data. A Phase IIa trial targeting heart attack patients is slated for early 2026.
- Five Phase I cohorts completed without safety issues; sixth cohort dosed
- Phase I protocol amended for higher doses and longer infusion
- Preclinical studies show significant neuroprotection in traumatic brain injury
- 42% cardioprotection and reduced arrhythmia in coronary heart disease model
- Phase IIa trial for acute myocardial infarction planned to start late Q1 2026
Phase I Trial Progress and Safety
Nyrada Inc (ASX, NYR) has reported encouraging progress in its Phase I clinical trial of Xolatryp, its lead drug candidate targeting neuroprotection and cardioprotection. The company successfully completed dosing in five cohorts with no safety signals, dose-limiting toxicities, or unexpected side effects. The sixth cohort has also been dosed and discharged without adverse events, with final trial readouts expected by September 2025.
Reflecting the strong tolerability observed, the trial protocol was recently amended to allow testing of higher doses and longer infusion durations. This flexibility aims to better optimize dosing regimens for future patient populations, particularly as Nyrada prepares for Phase II studies.
Compelling Preclinical Efficacy Data
Beyond clinical safety, Nyrada has bolstered confidence in Xolatryp’s therapeutic potential through a series of preclinical studies. A collaborative traumatic brain injury (TBI) study with the Walter Reed Army Institute of Research and UNSW Sydney demonstrated a statistically significant neuroprotective effect following penetrating TBI, marking a critical validation of Xolatryp’s mechanism.
In cardiovascular research, a follow-up coronary heart disease study revealed that Xolatryp delivered 42% cardioprotection when administered continuously for just three hours post-acute myocardial ischemia. Notably, the treatment also significantly reduced the incidence of arrhythmias such as ventricular fibrillation and ventricular tachycardia, which are leading causes of sudden cardiac death.
Looking Ahead, Phase IIa Trial and Financial Position
Building on these promising results, Nyrada plans to initiate a Phase IIa clinical trial targeting patients with acute myocardial infarction (AMI) in the quarter ending March 2026. This trial will assess both safety and efficacy over a six to nine month period, representing a pivotal step toward potential regulatory approval and commercialisation.
Financially, Nyrada ended the quarter with AU$2.93 million in cash, down from AU$4.76 million the previous quarter, reflecting operating outflows of approximately AU$1.9 million. The company has indicated plans for a capital raise to support ongoing operations and clinical development, underscoring the importance of prudent financial management as it advances its pipeline.
Director fees and related party payments amounted to AU$156,000 for the quarter, consistent with prior periods. Nyrada’s strategic focus remains on leveraging its innovative TRPC ion channel inhibitor platform to deliver first-in-class therapies addressing significant unmet medical needs.
Bottom Line?
With Phase I safety confirmed and compelling preclinical efficacy, Nyrada’s upcoming Phase IIa trial will be critical to watch as it seeks to translate promise into patient benefit.
Questions in the middle?
- Will the Phase I trial’s final readouts confirm safety at higher doses and longer infusion times?
- How will the Phase IIa trial design leverage the amended dosing flexibility to maximize efficacy?
- What are the prospects and timeline for Nyrada’s planned capital raise to sustain clinical development?