Nyrada (ASX:NYR), a drug discovery company focused on small molecule therapies, has announced the successful completion of critical safety studies for its lead candidate NYR-BI03. The drug, designed to treat neuroprotective and cardioprotective conditions such as stroke and traumatic brain injury, is on track for its first-in-human clinical trials in late 2024.
Preclinical studies, including 14-day toxicology tests on rats and dogs, showed that NYR-BI03 was well tolerated, bolstering confidence in its safety profile. These findings will support Nyrada’s submission to the Human Ethics Research Committee, a key regulatory step for launching the Phase I trial. The upcoming study will assess the safety and pharmacokinetics of the drug in healthy volunteers, with results expected by mid-2025.
NYR-BI03 has demonstrated promising results in preclinical models, offering significant protection to brain tissue following a stroke and reducing heart damage by 86% in models of coronary ischaemia. This positions the drug as a potential game-changer in both neuroprotection and cardiovascular health.
Nyrada’s progress with NYR-BI03 marks a significant step forward in addressing unmet medical needs in both brain injury and heart disease, fields with considerable market potential.
