Shares in Nyrada Inc (ASX: NYR) hit a new high-water mark for the year after the company said it had received ethics approval to conduct a Phase II clinical trial of its flagship drug candidate in patients who have suffered a heart attack.
The biotechnology company's shares have been trending sharply higher, particularly since mid-October, and are now up almost 20-fold from levels as low as 7.4 cents about this time a year ago.
The shares hit a new 12-month high of $1.43 on the clinical trial news on Thursday, meaning shareholders are sitting on an almost 20-fold return over a year.
Image source: Getty Images
Trial set to start soon
The company said on Thursday it had received ethics approval to go ahead with its Phase II trial of the compound Xolatryp, which will be tested for its use in treating "myocardial ischemia reperfusion injury in patients suffering a heart attack''.
The company went on to say:
The trial is a randomised, double-blind, placebo-controlled, multicentre study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Xolatryp in male and female patients of non-childbearing potential presenting with a heart attack undergoing primary percutaneous coronary intervention or angioplasty with stenting. Approximately 200 patients will be dosed for this 1:1 drug to placebo trial.
The company said while safety was the primary endpoint for the trial, multiple efficacy signals were also being evaluated, including cardiac function, extent of cardiac injury, and the incidence of arrhythmias of interest.
The ethics approval allows the company to start establishing trial sites across Australia, with patient approval expected to start in March and up to 10 hospitals excepted to be involved.
The company said that "subject to recruitment rates, the trial is expected to conclude within nine to 18 months of first patient dosing''.
The company added:
Recruitment timelines will be closely monitored, and Nyrada's study plan allows for flexible expansion to additional hospitals in Australia or internationally to further strengthen participation. Countries with well-aligned regulatory frameworks, such as New Zealand, Singapore, and Canada, offer potential avenues for broadening the trial's reach.
According to the company's website, "Xolatryp, is designed to offer cardioprotection by preventing calcium ion overload in heart cells, thereby enhancing patient outcomes. Because heart cells cannot regenerate after death, this approach is critical for recovery".
The company said that in preclinical studies, "Xolatryp provided 86% cardioprotection when administered intravenously over 24 hours, starting 30 minutes post-MI event. Additionally, Xolatryp improved cardiac function and significantly reduced injury-related biomarkers''.
Nyrada was valued at $336.1 million at the close of trade on Wednesday.
