Nyrada Inc. (ASX: NYR) have released results from an animal study of their lead Brain Injury program drug candidate NYR-BI03. The trial involving 16 animals demonstrated statistically significant neuroprotection compared to placebo, signalling strong evidence of efficacy. The trial involved treatment with NYR-BI03 or placebo 30 minutes following the induced brain injury (in order to replicate a stroke), with treatment conducted for 72 hours via continuous intravenous infusion. Magnetic Resonance Imaging (MRI) was used to evaluate brain injury in both drug treated and vehicle (placebo) animals. MRI data was used to determine the level of tissue damage in the penumbra region of the brain, the area of secondary brain injury that the NYR-BI03 neuroprotection drug targets. The analysis was performed blinded so the researcher did not know whether an animal had received the drug or placebo. Blood samples were analysed for changes in the biomarker neurofilament light (Nfl), which is a protein associated with neuron fibre tracts. Following a brain injury, neurons are damaged, and the Nfl protein is released into the bloodstream. The results showed that a statistically significant level of neuroprotection was achieved with NYR-BI03 rescuing an average of 42% of the brain injury in the penumbra region of the brain. All animals survived the brain injury and drug treatment with no drug-related adverse effects reported.
Nyrada CEO James Bonnar commented “These study results mark a significant milestone in our Brain Injury program, providing strong evidence that our drug candidate NYR-BI03 has the potential to protect the brain from secondary injury. The magnitude of rescue achieved in this study is a compelling outcome and signals a significant therapeutic and market opportunity. This work is critical for our development pathway for NYR-BI03, giving us confidence as we advance it through to GLP safety and toxicology studies ahead of a first-in-human clinical trial, currently planned to commence in the second half of this calendar year.”
Next Steps
Nyrada will now begin Good Laboratory Practice (GLP) studies with NYR-BI03 this quarter to assess the safety of the molecule in two animal species. This study is necessary to demonstrate the safety of the drug candidate prior to entering a first-in-human clinical trial (Phase I).
Subject to positive results from the GLP studies, the Phase I trial will commence during the second half of 2024. A Contract Research Organisation has been engaged for this purpose.
Planning and preparation work for the Walter Reed TBI study has been completed. The study will assess the efficacy of NYR-BI03 in a penetrative brain injury model, a type of injury which is a common occurrence amongst army veterans. The study will take six months to complete.
