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Sydney-based drug development company Nyrada Inc (ASX:NYR) has completed an in vivo micronucleus study on rats which has supported expectations of safety for its NYR-BI03 drug candidate – particularly in terms of genetic damage – ahead of Phase 1 human trials later this year.
The study – completed as part of Nyrada’s brain injury program Good Laboratory Practices (GLP) – found there was no increase in markers of genotoxicity in treated animals compared with control treated animals.
NYR-BI03 is being developed to treat both stroke and traumatic brain injury (TBI), and these results follow on from news in February that a preclinical stroke study had shown the drug to have achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals.
In October, a preclinical coronary heart disease study demonstrated that the drug bestowed an 86% cardioprotection effect following myocardial ischemia-reperfusion injury, with this being statistically significant.
Once all GLP studies are complete, Nyrada will move on to submitting a Human Research
Ethics Application with the expectation of commencing its first in human Phase I clinical trial in late 2QFY2025 (quarter ending December 2024).
The market appeared happy with the news, and by 12:18 AEDT, shares in Nyrada were trading at 10.5 cents – a rise of 4.99% since the market opened.
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