Neuroprotection – Brain Injury Drug

Nyrada’s is developing a new and novel drug that reduces the long-term disability associated with stroke or traumatic brain injury (TBI) by limiting the number of brain cells that die post-injury. Currently, no treatments exist for TBI therefore the global market potential for a new drug that reduces the damage to the brain following a stroke or injury is very large.

Currently, approximately 15 million people suffer stroke worldwide each year. Of those, approximately one-third will die shortly after suffering a stroke, one-third will recover with little or no permanent disability, and one-third will be permanently disabled requiring long-term support and assistance. The neuroprotection drug development program aims to improve patient outcomes and increase the likelihood of recovery, shorten rehabilitation times and reduce the economic burden to the health system.

In the US, a stroke occurs every 40 seconds and a TBI every 15 seconds. The combined economic burden for stroke and TBI in the US amounts to more than US$100 billion in direct and indirect costs.

Concussion or mild TBI in contact sports accounts for 80% of all TBI cases and is a major cause of cognitive impairment and long-term physical illness. Repeated concussions lead to chronic traumatic encephalopathy (CTE) and brain degeneration caused by repeated head traumas. The incidence of concussion can range from 14.8-28.3 per 1000 player match hours. The economic burden of costs for rehabilitation and ongoing care for people who have suffered a TBI is very high.

Nyrada hopes to reduce long-term disabilities that occur in people who have had a stroke or traumatic brain injury by limiting the extent of brain cell loss post-injury. The program aims to increase the chances of recovery by reducing secondary brain damage and rehabilitation times and the burden on healthcare systems as a result.

The drug would be taken over 3-4 days beginning a soon as possible after a brain injury to disrupt and reduce excitotoxicity, which is largely responsible for secondary brain damage to the brain. Excitotoxicity is a common occurrence after stroke or traumatic brain injury. Chemicals are released from dead and dying brain cells, which have been impacted by the original injury. The chemicals affect healthy brain cells that cover a larger area than the core injury causing the death of brain cells. Long-term disabilities result from an almost doubling in size of the original injury.

Secondary brain injury can more than double the total area of brain injury following a stroke or TBI and there is currently no treatment to stop cell death. Nyrada has developed a novel family of molecules, which can stop the excitotoxicity process.

In a laboratory study, Nyrada’s drug candidates showed the ability to cross the blood-brain barrier and achieve concentrations anticipated to be therapeutic.

Collaboration Agreement with the Walter Reed Army Institute of Research & UNSW

A Collaboration Agreement with the specialist TBI research team at Walter Reed Army Institute of Research (WRAIR) & UNSW Sydney has been successfully negotiated. This will enable Nyrada to examine the ability of its lead neuroprotection compound to minimise the process responsible for secondary damage to the brain amongst military personnel who suffer a TBI during their active service careers. The agreement aligns Nyrada with WRAIR’s mission to develop ground-breaking treatments to mitigate the impacts of traumatic brain injury which occurs in 1 in 25 service members. The agreement may also provide Nyrada with access to non-dilutive funding to further develop its neuroprotection program.

Brain Injury Preclinical study and Phase 1 Study Design – NYR-B103

In February 2024 Nyrada completed a preclinical stroke study to assess the efficacy of NYR-BI03. The study showed a significant neuroprotective signal providing strong evidence of efficacy. The study, conducted in collaboration with UNSW Sydney, involved inducing a focal ischemic stroke using a photothrombotic model (a minimally invasive and reproducible way of inducing focal brain injury in test animals). A total of 16 test animals were treated with either NYR-BI03 or a placebo 30 minutes following the induced brain injury, with treatment conducted for 72 hours via continuous intravenous infusion. Magnetic Resonance Imaging (MRI) was performed to quantify the brain injury in drug-treated and placebo animals. The MRI data determined tissue damage in the penumbra region, the area of secondary brain injury that the NYR-BI03 neuroprotection drug targets. 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.

These analyses were performed blinded, where the experimenter did not know if a particular animal received NYR-BI03 or a placebo.

Subject to the successful completion of Good Laboratory Practice (GLP) safety testing, Nyrada will commence a Phase I human clinical trial for NYR-BI03. The Company has already undertaken necessary planning and engaged a Contract Research Organisation for this purpose. The target commencement of a Phase I trial is anticipated to start in the second half of the 2024 calendar year. The data from the GLP studies and Phase I trial will support the Phase II trials of NYR-BI03 for both TBI and stroke indications.

Drug Discovery

In addition to Nyrada’s lead Cardiovascular and Neuroprotection drug development programs, the Company is investigating drugs to treat pain associated with peripheral nerve damage (Inflammation/Pain) and autoimmune diseases such as psoriasis (Autoimmune).

The Inflammation/Pain and Autoimmune programs are part of a larger pipeline of potential drug candidates that Nyrada continues to evaluate and develop while focusing on the progression of its two lead drug development programs.

Further information concerning Nyrada’s drug development program can be obtained from following the links below.

Inflammation/Pain

Autoimmune