Nyrada Inc (ASX:NYR) has received approval from the Human Research Ethics Committee (HREC) to amend its Phase I clinical trial protocol for Xolatryp™, a drug being developed for cardioprotection and neuroprotection. The amendment allows for the evaluation of Xolatryp’s safety, tolerability, and pharmacokinetics at higher doses and over a longer infusion duration in healthy volunteers. This decision was influenced by the strong tolerability observed in previous lower-dose cohorts. The modified protocol enhances Nyrada’s flexibility in designing a Phase II trial, enabling the optimisation of dosing for the intended patient population.
The Phase I trial will now consist of six cohorts to incorporate the protocol amendments. However, the final Phase I trial results are still expected in the quarter ending September 2025. Nyrada has completed the first three cohorts of its Phase I clinical trial, with the fourth cohort dosed and data under analysis for the Safety Review Committee’s assessment.
Xolatryp has demonstrated preclinical efficacy as an acute treatment following ischemic stroke, traumatic brain injury (TBI), and acute myocardial infarction (AMI). Preclinical stroke study results showed that Xolatryp achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals. A preclinical coronary heart disease study showed that Xolatryp provided an 86% cardioprotective effect following myocardial ischemic-reperfusion injury. Follow-up studies showed 42% cardioprotection with continuous 3-hour administration and a significant reduction in arrhythmia parameters, including ventricular fibrillation and ventricular tachycardia.
A traumatic brain injury study, conducted in collaboration with the Walter Reed Army Institute of Research and UNSW Sydney, showed that Xolatryp provided a statistically significant neuroprotective effect following penetrating TBI. Nyrada will continue to provide updates on the Phase I trial, which has been registered with the US National Institutes of Health.
