Phase I Safety Success for Nyrada, But Will Phase IIa Deliver Efficacy?

Positive Safety Review Marks Phase I Completion

Nyrada Inc. has announced a significant milestone in the development of its lead drug candidate, Xolatryp™, with the Safety Review Committee (SRC) concluding a positive final assessment of its Phase I clinical trial. The trial, which enrolled 48 healthy volunteers across six cohorts, found no dose-limiting toxicities or serious adverse events, confirming that Xolatryp is well tolerated even at doubled infusion durations.

The Phase I study was designed to evaluate safety and pharmacokinetics of Xolatryp administered intravenously over three or six hours. The final cohort received a six-hour infusion at the same concentration as the previous cohort, effectively doubling the dose exposure. The SRC’s review found consistent safety profiles and predictable pharmacokinetics, with linear drug clearance and stable distribution volumes, which are encouraging indicators for dosing control in future studies.

Next Steps – Data Lock and Phase IIa Planning

With participant assessments complete, Nyrada is finalizing data cleaning and anticipates locking the trial database by the end of August 2025. The unblinding of data and release of topline results are expected in the September quarter, providing further clarity on the drug’s safety and tolerability compared to placebo.

Looking ahead, Nyrada plans to initiate a Phase IIa clinical trial in early 2026. This next phase will focus on patients experiencing acute myocardial infarction, specifically those undergoing Percutaneous Coronary Intervention (PCI) for ST-Elevation Myocardial Infarction (STEMI). The Phase IIa trial aims to explore both safety and preliminary efficacy, building on the promising preclinical data that demonstrated significant cardioprotective and neuroprotective effects of Xolatryp.

Building on Robust Preclinical Foundations

Xolatryp’s development is underpinned by a series of compelling preclinical studies. Notably, a May 2025 study showed a 42% cardioprotective effect after just three hours of continuous administration, alongside a marked reduction in life-threatening arrhythmias. Earlier research demonstrated an 86% cardioprotective effect following ischemic-reperfusion injury, and significant neuroprotection in models of stroke and traumatic brain injury, including collaborative work with the Walter Reed Army Institute of Research and UNSW Sydney.

These findings position Xolatryp as a first-in-class small molecule with dual cardioprotective and neuroprotective potential, addressing critical unmet needs in acute cardiovascular and neurological injury treatment.