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Drug development company Nyrada (ASX:NYR) has dosed the first cohort of patients in a trial to assess its lead drug candidate NYR-BI03 – which is seeking to reduce the long-term disability associated with stroke or traumatic brain injury (TBI) as well as damage to the heart after disease and injury.
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The Phase I first-in-human trial is assessing NYR-BI03’s safety and tolerability as well as scrutinising its pharmacokinetics (how the body interacts with the drug).
All participants have now been dosed and discharged.
Of these, six received NYR-BI03 while two participants received a placebo.
Once each cohort is completed, the Safety Review Committee will review the accumulated data on safety and pharmacokinetics, with further dose cohorts only going ahead after favourable review and approval by the SRC.
This development follows Nyrada’s report in February 2024 of preclinical stroke study results, which indicated that the drug candidate was able to meet a statistically significant neuroprotective effect, achieving the rescue of 42% of brain tissue in the penumbra region of treated animals.
Later that year, in October 2024, the company reported on a preclinical coronary heart disease study which revealed an 86% cardioprotective effect produced by NYR-BI03 following myocardial ischemic-reperfusion injury – a significant cause of tissue damage that occurs when blood flow is restored to the heart after injury.
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Final Phase I trial readouts are now expected in the third quarter of 2025.
NYR shares last traded at 10.5 cents – a fall of 4.54% since the market opened.
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