Nyrada (ASX:NYR) has commenced recruitment for its phase one clinical trial of its lead drug candidate NYR-BI03.
The company is developing Transient Receptor Potential Canonical (TRPC) ion channel blockers.
The new trial is designed to assess the safety, tolerability, and pharmacokinetics of NYR-BI03.
NYR-BI03 is a small molecule, first-in-class investigative neuro-protection and cardio-protection treatment. In February 2024, Nyrada announced preclinical stroke study results showing it achieved a statistically significant neuro-protective effect, rescuing 42 per cent of brain tissue in the penumbra region of treated animals. In October 2024, the company announced the results of a preclinical coronary heart disease study, which showed that NYR-BI03 provided an 86 per cent cardioprotective effect following myocardial ischemic-reperfusion injury.
The new trial will be a double-blind, randomised, placebo-controlled, dose-escalating study comprising five cohorts of eight healthy participants receiving an intravenous dose of either NYR-BI03 or placebo over three hours. There will be six active and two placebo participants per cohort. After each completed cohort, the Safety Review Committee will review accumulated safety and pharmacokinetic data. The company said the final trial readouts are expected in the third quarter of calendar year 2025.
