Traumatic brain injuries (TBI) are usually caused by a blow to the head or when an object (like a bullet or flying debris from a car accident) penetrates the brain. TBIs can be long lasting and difficult to treat, causing symptoms that range from dizziness, loss of balance and mood changes to seizures, cognitive issues and inability to speak or move correctly.
Children, the elderly, members of armed forces and athletes are most likely to suffer from a TBI. The estimated lifetime costs of TBI in the U.S. are $80 billion. Numbers of cases and deaths related to TBI have increased by 53% since 2006. There were 27 million new cases worldwide in 2016.
In March 2020, Keita Mori, president and co-CEO of regenerative medicine company SanBio, of Japan and California, called for the U.S. to create a nationwide TBI registry to help improve research and treatments. Few treatments have been available for the condition, although a year ago, the U.S. Department of Veteran’s Affairs announced plans to spend $50 million in search of a treatment.
Now, publicly traded newbie biotech NervGen Pharma Corp. may be close to getting investigational new drug (IND) approval for its drug NVG-291 from the U.S. Food and Drug Administration (FDA), to be used to treat TBI and conditions where the brain has sustained damage. The drug is expected to enter phase I trials in the first half of 2021. NervGen recently added an advisor from the U.S. Department of Defense who is an expert on traumatic brain injury (TBI): Retired Colonel Dr. Michael David, former director of the U.S. Combat Casualty Care Research Program. Dr. David will help NervGen gather funding and explore uses of NVG-291 in TBI.
According to NervGen CEO Paul Brennan, TBI “behaves as if it were diffuse spinal cord injury” at the cellular level.
Getting FDA approval has proved elusive for NervGen before, although the regulatory agency did earlier approve intracellular sigma peptide (ISP), a rPTP-sigma antagonist made by NervGen. In mice, ISP stimulated certain cells that could aid with myelin repair to enter MS lesions. Myelin is the fatty sheath surrounding and protecting nerves. Without myelin, nerves do not function correctly. Treatment with ISP also increased levels of proteases (protein-cutting enzymes) that break down scar tissue in nerves.
NVG-129 is an analog of ISP that targets the receptor for the protein tyrosine phosphatase sigma (PTPσ). In the central nervous system, this receptor can stop nerve regeneration, inhibit plasticity and inhibit remyelination when a nerve is damaged. Inhibiting the PTPσ receptor helped nerves regenerate in animal studies.
In phase II studies, the researchers will test NVG-129 for use in acute spinal cord injury, MS, Alzheimer’s dementia, stroke and TBI. If the drug works, NervGen’s market cap could go up substantially and the company is likely to receive additional funding and offers for joint ventures and partnerships. However, just the Alzheimer’s application alone could prove profitable for NervGen.
Disclaimer: This article does not provide medical advice. Do not take action based solely on this article and always consult with an appropriate healthcare professional. This article is purely for informational purposes.