Nyrada Successfully Completes Safety Studies Ahead of Phase I Clinical Trial

Nyrada Inc (ASX:NYR) has announced the successful completion of their Good Laboratory Practice (GLP) safety studies on its lead drug candidate NYR-BI03. These preclinical studies indicate NYR-BI03 is well tolerated with a favourable safety profile. Results from a 14-day rat toxicology study support finalisation of Nyrada’s regulatory submission. With the conclusion of GLP studies, Nyrada will now finalise its regulatory submission to the Human Ethics Research Committee (HREC) to enable a first-in-human Phase I clinical trial to commence later in Q4 2024.

NYR CEO James Bonnar commented on completion of the pre-clinical safety studies “We are thrilled to have completed the GLP studies, which have confirmed a favourable safety profile for NYR-BI03, giving us confidence that it will transition well into human studies. “The imminent progression of NYR-BI03 into clinical trials is exciting and will mark a significant milestone for the Company, particularly as we now have preclinical evidence supporting its efficacy in both neuroprotection and cardioprotection. This positions us to target three major markets with one therapeutic.

About NYR-BI03
Nyrada’s drug candidate NYR-BI03, has recently demonstrated remarkable efficacy in a recent preclinical study. This development not only reinforces our confidence in NYR-BI03’s potential in treating patients with stroke and Traumatic Brain Injury (TBI), but also opens a new therapeutic indication for Nyrada. The preclinical study results have demonstrated NYR-BI03’s strong efficacy in limiting cardiovascular damage associated with coronary heart disease following a heart attack. NYR-BI03 reduced cardiac tissue damage by 86% and this positions the drug as a promising novel treatment for myocardial infarction-reperfusion injury. NYR-BI03 also demonstrated superior efficacy compared to an existing FDA-approved therapy Captopril in protecting heart tissue following myocardial ischemia-reperfusion injury. Nyrada continues to pioneer the development of TRPC channel-blocking therapies, with NYR-BI03 being a first-in-class drug with a novel mechanism of action.

Nyrada’s CEO, James Bonnar, expressed his enthusiasm about the new indication for NYR-BI03 as a potential drug to treat myocardial ischemia-reperfusion injury: “This is an exciting development for Nyrada, presenting additional therapeutic and commercial options for our lead drug candidate NYR-BI03. The cardiovascular study leverages Nyrada’s TRPC knowledge and expertise. The preclinical Good Laboratory Practice (GLP) package assembled for our brain injury program can also support clinical development in this indication. Nyrada continues to pioneer the development of TRPC channel-blocking therapies.”

The Transient Receptor Potential Canonical (TRPC) channel-blocking mechanism of NYR-BI03 is a groundbreaking development with significant implications for drug development and cardiovascular therapies. This novel approach is highly significant for several reasons:

• NYR-BI03 has shown neuroprotective properties. A preclinical stroke study in mice revealed that it rescued 42% of the penumbra region in animals treated with the drug.
• NYR-BI03 demonstrated 86% cardioprotection following myocardial ischemia-reperfusion injury in a preclinical rat study. This significant reduction in cardiac tissue damage positions NYR-BI03 as a promising treatment for myocardial infarction-reperfusion injury.
• The TRPC channel-blocking mechanism allows NYR-BI03 to potentially treat traumatic brain injury with results of a study in a rat model at the Walter Reed Army Institute of Research (WRAIR) due to be received early in the next quarter.
• NYR-BI03 is pioneering TRPC channel-blocking therapies, making it a first-in-class drug with a novel mechanism of action.
• The drug specifically blocks TRPC3, TRPC6, and TRPC7 channels, which are primary drivers secondary brain injury and heart tissue damage through calcium ion overload, a process called excitotoxicity.
• This versatility opens significant market opportunities, with the global market for myocardial infarction therapies alone projected to reach US$3.7 billion by 2032.
• The preclinical Good Laboratory Practice (GLP) package being assembled for the brain injury program can also support clinical development for cardiovascular indications, streamlining the development process.
• Only one Phase I trial is required prior to commencing multiple Phase II trials to measure efficacy for stroke, TBI and myocardial infarction-reperfusion injury.

While TRPC channels have been studied before, NYR-BI03 is the first drug candidate to specifically target these channels for therapeutic purposes in neurological and cardiovascular conditions. These therapies represent a new approach to treating conditions like stroke, TBI, and coronary heart disease. By being the first to develop a drug that specifically targets TRPC channels for these therapeutic applications, NYR-BI03 is breaking new ground in drug development, making it a true first-in-class therapy.

NYR-BI03 – A significant Opportunity Across Multiple Indications
The novel mechanism of action positions NYR-BI03 as a potentially groundbreaking treatment for myocardial infarction-reperfusion injury, offering a new approach to cardioprotection that differs substantially from existing therapies. By specifically blocking TRPC channels involved in calcium ion-mediated excitotoxicity, NYR-BI03 addresses a key mechanism of cardiac cell injury during coronary events that is not directly targeted by existing treatments. In the preclinical rat study, NYR-BI03 showed superior efficacy compared to Captopril, an FDA-approved ACE inhibitor commonly used following ischemic events. NYR-BI03 has also demonstrated neuroprotective properties for stroke and is currently being investigated in a rat model as a potential treatment for TBI, which is highlighted as a key health concern for the the US military.

Challenges
As a first-in-class drug with a novel mechanism of action, NYR-BI03 may face increased scrutiny from regulatory bodies like the FDA. A Phase I clinical trial, scheduled to commence in Q2 FY2025, needs to be successfully completed. This objective of this trial is to confirm the safety and tolerability of the drug in humans. Subsequent Phase II trials for multiple indications (stroke, traumatic brain injury, and myocardial ischemia-reperfusion injury) will require careful planning and execution. The cardiovascular and neurological drug markets are highly competitive so Nyrada will need to demonstrate clear advantages over existing therapies, where they exist. While the drug’s potential to treat multiple is advantageous, it also presents challenges in terms of prioritising indications and managing resources across multiple development programs. There may be opportunities to bring in partners for specific indications to attract additional non-dilutive funding into the company.