On Tuesday morning, Nyrada Inc. (ASX: NYR) released a significant announcement about a potential new indication for its lead drug candidate NYR-BI03. In a preclinical rat study, NYR-BI03 demonstrated strong efficacy limiting cardiovascular damage associated with coronary heart disease, indicating 86 percent cardio protection following myocardial ischemia-reperfusion injury (heart attack). NYR-BI03 is a new, first-in-class neuroprotection treatment for both stroke and traumatic brain injury (TBI). The results from this study provides the company with an additional therapeutic opportunity which has significant market potential (subject to successful clinical trials).
Announcement Highlights
NYR-BI03 demonstrated superior efficacy in this study compared to Captopril, an FDA-approved therapy.
Broadens potential therapeutic application of NYR-BI03 to include coronary heart disease.
Global market for myocardial infarction therapies is anticipated to reach US$3.7 billion by 2032 offering an additional and significant market opportunity for Nyrada.
Nyrada is pioneering Transient Receptor Potential Canonical (TRPC) channel-blocking therapies and NYR-BI03 is first-in-class with a novel mechanism of action.
Phase I clinical trial for NYR-BI03 scheduled to commence in 2QFY2025.
The rat study demonstrated that NYR-BI03 had strong efficacy in limiting cardiovascular damage following acute myocardial ischemic[1]reperfusion injury. Ischemic-reperfusion injury is a leading cause of tissue damage following the restoration of blood flow to the heart post-injury. NYR-BI03 demonstrated strong and statistically significant cardioprotection following a myocardial infarction by reducing cardiac tissue damage by 86 percent (p value < 0.001, n=8 per group). A p value of <0.001 is highly significant in that it indicates a very high probability that NYR-BI03 is responsible for limiting the damage to heart tissue following a heart attack.
In February 2024, the Company reported preclinical stroke study results showing NYR-BI03 provided a statistically significant level of neuroprotection, rescuing 42% of brain injury in the penumbra region in treated animals. Published research has shown that blocking TRPC channel activity also significantly protects cardiac tissue from ischemic reperfusion injury. One of the primary drivers of heart damage in cardiovascular disease is the activation of calcium (Ca2+) ion channels, specifically TRPC3, TRPC6, and TRPC7 which mediate cardiac cell injury during coronary events. NYR-BI03 has been specifically designed to block these channels.
Nyrada commissioned a rat study in a model of acute myocardial ischemia-reperfusion injury to assess the cardio protective efficacy of NYR-BI03. The results demonstrated strong cardio protection that was superior to Captopril, an FDA-approved ACE inhibitor commonly administered following ischemic events and used in this study as a positive control. This positions NYR-BI03 as a novel cardioprotective treatment following myocardial infarction. Myocardial infarction is a leading cause of morbidity and mortality worldwide, with a global market for treatments anticipated to grow at a CAGR of 6.8 percent and reach US$3.7 billion by 2032.
NYR-BI03 is currently undergoing GLP safety and tolerability studies ahead of a first-in-human Phase I clinical trial expected to commence in the quarter ending December 2024. Six out of nine GLP studies have been completed with three remaining. Subject to satisfactory completion of this Phase I trial, NYR-BI03 has the potential to progress directly to Phase II trials to assess its efficacy in stroke, traumatic brain injury, and now myocardial ischemia-reperfusion injury. Nyrada has also very recently submitted patent protection applications for its TRPC channel-blocking therapies, including for brain injury and coronary heart disease
There is a substantial amount of news flow due in the next three months including completion of GLP studies for NYR-BI03 followed by a commencement of a first in human phase I clinical trial. The results from the Traumatic Brain Injury trial in rats being conducted by the Walter Reed Institute of Army Research is also due early in Q1 FY2025, which could lead to significant non-dilutionary funding for the TBI program.
