Nyrada (ASX:NYR) has announced the completion of the final GLP safety study for its lead candidate NYR-BI03.
The company is focused on developing novel small molecule Transient Receptor Potential Canonical (TRPC) ion channel-blocking therapies.
It said it is now finalising its regulatory submission to the Human Ethics Research Committee (HREC) for its first-in-human Phase 1 clinical trial, which it expects to begin in the fourth quarter of 2024.
CEO James Bonnar said, "We are thrilled to have completed the GLP studies, which have confirmed a favourable safety profile for NYR-BI03, giving us confidence that it will transition well into human studies.
"The imminent progression of NYR-BI03 into clinical trials is exciting and will mark a significant milestone for the Company, particularly as we now have preclinical evidence supporting its efficacy in both neuroprotection and cardioprotection. This positions us to target three major markets with one therapeutic."
NYR-BI03 is a first-in-class neuroprotection treatment for stroke and traumatic brain injury (TBI).
In February 2024, Nyrada announced preclinical stroke study results showing that NYR-BI03 achieved a statistically significant neuroprotective effect, rescuing 42 per cent of brain tissue in the penumbra region of treated animals.
Earlier this month, the company announced the results of a preclinical coronary heart disease study, which showed that NYR-BI03 provided an 86 per cent cardioprotective effect following myocardial ischemic-reperfusion injury, a leading cause of tissue damage when blood flow is restored to the heart after injury.