The aim of the Company’s neuroprotection program is a new and novel drug that reduces the long-term disability associated with stroke or traumatic brain injury by limiting the number of brain cells that die post injury.
Currently, approximately 15 million people suffer stroke worldwide each year. Of those, approximately one-third will die shortly after suffering stroke, one-third will recover with little or no permanent disability, and one-third will be permanently disabled requiring assisted living. The aim of the Nyrada program is 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.
MARKET INFORMATION ON STROKE AND TBI
- Approximately 15 million people suffer stroke worldwide each year.
- Approximately 5 million recover with little or no permanent disability, approximately 5 million are permanently disabled requiring assisted living, and approximately 5 million die.
- Each year in US, approximately 800,000 people suffer a stroke. About 600,000 of these are first attacks with the remainder as current attacks.
- Stroke is the third leading cause of death in the U.S.(about 140,000 people each year) and is the leading cause of serious, long-term disability in the U.S.
- In 2017 there were more than 56,000 new and recurrent strokes in Australia.
- These statistics are indicative of the global health burden from stroke.
- In the US, it is estimated that around 2.8 million people sustain a TBI annually and approximately 10% of these are related to sport and recreational activities.
- In addition, over 200,000 service members in the U.S. military (over 4.2% of all service members) were diagnosed with TBI between 2000 and 2011.
- Mild TBI, also known as concussion, accounts for 70-90% of all TBI cases and caused by blunt non-penetrating head trauma.
The goal is for the Nyrada drug to be administered over 3-4 days commencing, soon after the brain injury, in order to interrupt and minimise the excitotoxicity process responsible for secondary damage to the brain.
THE EFFECT OF TIME ON THE EXTENT OF DEATH OF BRAIN CELLS FOLLOWING A STROKE
Excitotoxicity is a common event in different forms of brain damage, including stroke and traumatic brain injury. It refers to a wave of chemicals released from the dead and dying brain cells affected by the original injury. These chemicals diffuse out from the core injury, over-stimulating healthy brain cells surrounding the core injury to the point of causing their death. This secondary wave of brain cell death can more than double the size of the original core injury, thereby contributing significantly to any long-term disability.
The main forms of brain injury associated with excitotoxicity are ischaemic stroke, traumatic brain injury (TBI), and severe epileptic seizure.
The current treatment for stroke is aimed at restoring blood supply to the brain as quickly as possible to minimise the number of brain cells killed by the original injury. This involves attempts to remove the obstruction in the affected brain artery either by dissolving it with a drug or physically removing it with a wire passed up the carotid artery. To be effective, these treatments are time-critical, needing to be administered within about 4 hours of the stroke. They also come with a range of restrictions, meaning that fewer than 1 in 10 stroke patients typically receive these treatments.
Beyond this immediate issue of the size of the core area of primary brain death that is determined within the 4-5 hours post-stroke, lies the secondary effect of the excitotoxicity process taking place over the next 3-4 days. Currently, there is no effective treatment to stop this wave of secondary brain death that can more than double the eventual area of brain death.
In conjunction with an Australian university research team who have made an important breakthrough discovery in relation to the excitotoxicity process, Nyrada has identified a novel family of molecules that effectively block the excitotoxicity process both in the laboratory and in an animal model of human stroke.
The Company is confident that it now can develop a first-in-class neuroprotectant drug capable of slowing down the excitotoxicity wave of damage, limiting its impact on long-term symptoms and doing so in a well-tolerated way.
The following video explains how excitotoxicity occurs and how Nyrada’s drug works to minimise secondary brain injury.