Nyrada (ASX:NYR) has provided an update on the development of its brain injury program with investigative first-in-class neuroprotection treatment, NYR-BI03.
In February this year, the company reported preclinical stroke study results showing NYR-BI03 provided a statistically significant level of neuroprotection, rescuing 42 per cent of brain injury in the penumbra region in treated animals.
Good Laboratory Practice studies commenced in March 2024 to assess the safety and tolerability of NYR-BI03.
Nyrada has reported that NYR-BI03 demonstrated safety and tolerability in a dog cardiovascular study. The company said its dog cardiovascular study assessed the effects of NYR-BI03 on heart function, blood pressure, and overall cardiovascular health via ECG.
The company said it had completed the regulatory cardiac safety profiling of NYR-BI03 necessary to commence a Phase I study. It added that based on the satisfactory completion of all GLP studies, it would submit a Human Research Ethics Application with the expectation of commencing its first-in-human Phase 1 clinical trial in late calendar year 2024.