Drug discovery and development company Nyrada Inc (ASX:NYR) has successfully completed the final GLP safety study for its lead candidate NYR-BI03.
The Company is now finalising its regulatory submission to the Human Ethics Research Committee (HREC), a critical step towards commencing its first-in-human Phase I clinical trial, anticipated to begin in Q4 2024.
"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,” CEO, James Bonnar, said.
"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."
Lead Asset: NYR-BI03
NYR-BI03 is a first-in-class neuroprotection treatment for stroke and traumatic brain injury (TBI). In February 2024, the company announced preclinical stroke study results showing that NYR-BI03 achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals.
Additionally, in October 2024, Nyrada announced the results of a preclinical coronary heart disease study which showed that NYR-BI03 provided an 86% cardioprotective effect following myocardial ischemic-reperfusion injury, a leading cause of tissue damage when blood flow is restored to the heart after injury.
GLP Safety Studies
Nyrada has now completed a 14-day rat toxicology study for NYR-BI03, in addition to an earlier reported 14-day dog toxicology study. These studies, conducted under GLP conditions, administered doses far exceeding the expected therapeutic levels, and showed that NYR-BI03 was well tolerated with no significant safety concerns observed.
This final toxicological assessment represents a major milestone for Nyrada, providing further confidence that the favourable safety profile observed in animals will likely translate to humans. Nyrada has also previously reported that GLP-compliant in vivo micronucleus and Ames studies indicated no genotoxic potential.
Based on these strong safety findings, Nyrada is moving forward with its HREC submission, with the pending in vitro micronucleus assay considered unnecessary for this submission given the clear negative results from the other genotoxicity tests. The in vitro study will be completed and form part of Nyrada’s Investigational New Drug (IND) application to the FDA.
Subject to HREC approval, Nyrada expects to commence a Phase I clinical trial of NYR-BI03 before the end of 2024. This study will assess the safety, tolerability, and pharmacokinetics of NYR-BI03 in healthy volunteers. Pharmacokinetic testing includes evaluating how the drug is absorbed, distributed, metabolised, and excreted in the body.
The Phase I trial, to be conducted in Australia, will provide valuable data applicable to both neuroprotection and cardioprotection programmes. The trial is expected to continue until the second half of calendar 2025.
