Novel small molecule therapies developer Nyrada Inc (ASX:NYR) has successfully completed an in vivo micronucleus study for its lead drug candidate, NYR-BI03.
This study, performed in rats and conducted under GLP conditions, assessed whether NYR-BI03 causes genetic damage. There was no increase in markers of genotoxicity in treated animals compared with control treated animals.
NYR-BI03 is a first-in-class neuroprotection treatment being developed for both stroke and traumatic brain injury (TBI).
In February 2024, the company announced preclinical stroke study results showing NYR-BI03 achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals.
In October 2024, Nyrada also announced the results of a preclinical coronary heart disease study. This study demonstrated that NYR-BI03 conferred a statistically significant 86% cardioprotection effect following myocardial ischemia-reperfusion injury. NYR-BI03 also demonstrated superior efficacy to Captopril, an FDA-approved therapy.
Subject to satisfactory completion of all GLP studies, Nyrada will submit 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).