Nyrada (ASX:NYR) has announced its intention to progress its candidate Xolatryp into a Phase 2a clinical trial for the treatment of acute myocardial infarction (AMI).
Nyrada is developing Xolatryp, previously known as NYR-BI03, a first-in-class small-molecule therapy for cardioprotection and neuroprotection.
Nyrada said its Phase 1 trial of Xolatryp is nearing completion, and that, when combined with strong preclinical evidence for cardioprotection in an infarct model, it has decided to proceed with the Phase 2a trial. The trial will evaluate Xolatryp as a first-in-class intravenous therapy to limit heart muscle damage and prevent arrhythmias during ischemia and after reperfusion in patients with ST-Elevation Myocardial Infarction (STEMI) that undergo Percutaneous Coronary Intervention (PCI).
Acute STEMI is a leading cause of mortality. A STEMI occurs when the coronary artery is blocked, impeding blood flow to a specific area of the heart and causing that region to become ischemic due to a lack of oxygen.
The standard treatment for STEMI is PCI, which involves inserting a catheter into the artery to remove the blockage and restore blood flow to the affected tissue and achieve vascular patency. However, the sudden return of the oxygen-rich blood to this ischemic area leads to reperfusion injury, contributing to the overall loss of functional heart tissue. There are no approved therapies that directly address ischemia and reperfusion injury, which significantly contribute to long-term cardiac damage following AMI. Xolatryp aims to fill this critical unmet therapeutic gap.
Nyrada CEO James Bonnar said, “This is a significant advancement for Nyrada and for patients who suffer from heart attacks. Reperfusion injury remains a serious unmet medical need, and Xolatryp offers a promising new approach with the potential to reduce cardiac events and prevent long-term heart damage.
“With a solid scientific basis and encouraging Phase I results, we are confident that this next phase will bring us closer to delivering a new class of therapy that could improve outcomes and reduce uncertainty and risk for millions of patients.”