Novel small molecule therapeutics specialist Nyrada Inc (ASX:NYR) has commenced a new brain injury good laboratory practice studies programme.
The company has recently completed a preclinical stroke study is evaluating NYR-BI03 in preventing secondary brain injury demonstrated evidence of neuroprotective efficacy. The study showed a statistically significant level of neuroprotection rescuing 42% of the brain injury in the penumbra region in animals receiving treatment.
The magnitude of rescue achieved was a compelling outcome signalling a significant therapeutic and market opportunity and providing the company confidence to proceed to good laboratory practice (GLP) safety studies. GLP studies are a regulatory precursor to a first-in-human clinical trial.
Nyrada can confirm that GLP studies are expected to continue for approximately six months. Elements of these GLP studies include but are not limited to cardiac safety, pharmacology, and toxicology tests.
Subject to positive outcomes from these GLP studies, Nyrada will commence a first-in-human Phase I clinical trial for NYR-BI03 in 2HCY2024. The purpose of the Phase I trial, expected to be conducted in Australia, will be to assess how NYR-BI03 affects the human body. This includes confirming safe dose ranges and identifying possible side effects.
“NYR-BI03 is a first-in-class therapy with a novel mechanism of action targeting significant market opportunity. Stroke and traumatic brain injury are leading causes of death and disability worldwide with no current FDA approved treatments,” CEO James Bonnar said.
“Given the strong efficacy and positive safety signals from our preclinical stroke study, we have now commenced the necessary GLP studies that will lead to human trials for NYR-BI03. This is a very exiting phase for Nyrada and our Brain Injury Programme.”
Walter Reed studies
Nyrada is additionally due to commence a collaborative brain injury study with the Walter Reed Army Institute of Research (WRAIR). WRAIR is a division of the US Army that was established to help solve disease and battle injury threats to soldiers.
This study will test the efficacy of NYR-BI03 in a rodent model of penetrating traumatic brain injury (PTBI) which mimics the serious head injuries suffered by military service members. The degree to which intravenous administration of Nyrada’s drug leads to a reduction in injury size following a PTBI will be assessed and measured.
Due to unplanned Walter Reed personnel non-availability, this study will now commence in early 2QCY2024. This study is still expected to be completed in 2HCY2024.