Nyrada pushes through to third cohort in Phase 1 trial for NYR-BI03

Nyrada Inc (ASX:NYR) is set to progress to the third cohort in its Phase 1 clinical trial assessing the safety, tolerability and pharmacokinetics of NYR-BI03 – its drug candidate which is being developed for neuroprotection and cardioprotection.

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The trial’s Safety Review Committee (SRC) has looked at cumulative safety and pharmacokinetic data – including from the second dosed cohort of participants – and concluded that there are no issues.

This means Nyrada can proceed to the third cohort, for which it is already recruiting participants. It is expecting final readouts for the Phase 1 trial to be completed by the third quarter of the 2025 calendar year.

The company’s expectations for NYR-BI03 have been bolstered by positive newsflow throughout much of last year and into 2025, starting with an announcement in February 2024 that preclinical stroke study results had shown the candidate had achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals.

This was followed by a preclinical study into coronary heart disease in October which revealed NYR-BI03 providing 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.

Finally, last month Nyrada told investors about the results of a preclinical traumatic brain injury study which indicated a statistically significant (p = 0.043) neuroprotective effect provoked by NYR-BI03 following a penetrating traumatic brain injury.

The study in question was undertaken in collaboration with the Walter Reed Army Institute of Research and UNSW Sydney.

Nyrada has been trading at 11 cents.

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