Nyrada (ASX:NYR), a clinical-stage biotechnology company developing TRPC ion channel inhibitors, has received approval from the Human Research Ethics Committee to commence its Phase 2a clinical trial of Xolatryp for treating myocardial ischemia reperfusion injury in heart attack patients.
The multicentre, randomised, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of Xolatryp in approximately 200 patients undergoing primary percutaneous coronary intervention or angioplasty with stenting.
While safety remains the trial's primary endpoint, secondary measures will include cardiac function, extent of cardiac injury, biomarker analysis, and incidence of arrhythmias.
Patient recruitment and dosing are expected to begin in March, with up to ten Australian hospitals participating initially.
Depending on recruitment rates, the trial could conclude within 9 to 18 months, with potential expansion to international sites, including New Zealand, Singapore, Canada, and the United States.
Xolatryp, formerly NYR-BI03, is a small molecule therapy that inhibits calcium entry via TRPC 3/6/7 channels, protecting mitochondrial function and reducing injury associated with heart attacks.
A Phase 1 trial has already established its safety and pharmacokinetics, paving the way for this next-stage study.
At the time of reporting, Nyrada's share price was $1.35.