Nyrada Inc. announced that its newest brain injury drug candidate, NYR-BI02 has shown excellent oral bioavailability and has been selected to advance into the company's Phase I first-in-human study. NYR-BI02 is the result of modifications made to NYR-BI01, improving the compound's overall drug-like properties. There is currently no FDA approved drug to treat secondary brain injury caused by TBI and stroke.

Recent exploratory pharmacokinetic studies undertaken as part of Nyrada's medicinal chemistry program revealed excellent oral bioavailability of NYR-BI02, indicating that Nyrada's drug has the potential to be administered orally to patients who suffer a concussion, where intravenous infusion is not preferred. The convenience of an oral dose form that can be administered in the field immediately after a concussion injury, without having to wait for hospitalisation, has the potential to significantly improve patient recovery outcomes. Optimisation of NYR-BI01 has led to an improved candidate NYR-BI02, which has a superior pharmacokinetic profile, meaning it is absorbed, metabolised, and cleared in a manner that supports oral dosing.

The Company engaged a contract research organisation (CRO) in China to undertake this study. Unfortunately, the commencement of this study has been delayed slightly as laboratory staff are temporarily unable to access work sites due to COVID-related lockdowns in Shanghai, China. Based on the latest information provided, The company expects the study to start shortly and anticipate results will be available in mid Second Quarter CY2022.

NYR-BI02 will be taken forward into the TBI efficacy study which will commence following completion of scale-up manufacturing. A pilot study was undertaken to optimise the design of the efficacy study. Data from this study will be used to determine the number of animals required to show a significant treatment effect.

Nyrada continues to work closely with the Walter Reed Army Institute of Research and UNSW Sydney as the program advances. As previously announced, the Company anticipates commencing a Phase I first-in-human study for its Brain Injury Program in the second half of CY2022. The Phase I study will be run in Australia and will evaluate the safety and tolerability of the Company's preferred brain injury drug candidate, NYR-BI02.

The Brain Trauma Neuroprotection (BTN) Branch is part of the Center for Military Psychiatry and Neuroscience at WRAIR. The primary mission of the BTN program is to develop ground-breaking solutions to mitigate the effects of TBI at the point of injury to reduce morbidity and mortality. Providing field-based options for diagnostics, preventive strategies, and treatments are critical to Soldiers.

Since 1893, the Walter Reed Army Institute of Research (WRAIR) has been a leader in solving the most significant threats to Soldier readiness and lethality such as disease and battle injury. WRAIR's broad research capabilities at its Washington, D.C., area and expeditionary laboratories function in concert to afford Soldiers the best medical protection and support possible before, during, and after deployment by addressing both longstanding and emerging threats. Though WRAIR's research is focused on Soldier health, its products have important civilian applications, saving countless lives around the world.

The Translational Neuroscience Facility (TNF) is a core neuroscience research platform in the Faculty of Medicine & Health at UNSW. The TNF broadly supports neuroscience research and advanced translational research training directed towards treatment of neurological disorders.