KAC Actions to Protect Combat Athletes are a Bold Move; But Let’s Keep Exploring New Options to Fight the Concussion Epidemic

We applaud the Kansas Athletic Commission’s  KAC) recent actions to help protect combat-sport athletes.  Their announcement is a bold first step in turning the tide on the concussion epidemic in Kansas and serves as a model for other states.

The KAC recently passed a measure to implement fighter and corner safety licensing protocols that will bring potentially life-saving education to professional fighters and teams competing in the state of Kansas.  That is something to celebrate.  While this move isn’t a knockout punch to eliminate or treat mild traumatic brain injury (mTBI) in the sport, adding concussion-related questions to the licensing process is a  powerful step forward. 

Fighting is more dangerous than most observers, and many athletes, understand.  About 3.8 million concussions occur in the U.S. each year from sports-related injuries.  While the Center for Disease Control estimates that 5-10% of athletes will experience a concussion in any given sport, [1]those numbers jump  significantly higher for combat sports. According to the Association of Neurological Surgeons, 90% of boxers will sustain a concussion during their careers. [2]

Concussions caused by contact sports are a growing epidemic in our country.  Jolts to the head frequently go unchecked. Many athletes shrug concussions off as nuisance and nothing more.  What may appear to some as a minor inconvenience can result in debilitating symptoms that can last months or  years.  As many as one third of patients do not fully recover from their concussions and those who have had a concussion are at risk of having another one.

Education is our best tool at this time to reduce the number of concussions and make sure that when fighters sustain head injuries, they report their symptoms, undergo a medical evaluation(s) and follow a doctor’s treatment plan before resuming physical activities. 

Promoting awareness about head injury is exactly what KAC hopes to achieve with its new mandate.  KAC announced that they will be partnering with the charity Fighting Foundation to add questions regarding concussions and chronic encephalopathy (CTE) to license applications for fighters and corners.  In their release, KAC indicated that persons involved in combat sports must educate themselves on the risks associated with brain injuries.

“There is no cure for CTE” said Fighting Foundation president Rose Grace, “however there is a cure for ignorance and it starts with our allies in Kansas.”

There is no cure for CTE, nor are there any effective pharmacological FDA-approved treatments for head injuries.  Treatment for concussions is still primitive and focuses on the symptoms rather than on a cure

 Several smaller biopharmaceutical companies like my own, Oxeia Biopharmaceuticals, have been conducting extensive research to treat concussions.  Kansas is playing yet another critical role as it relates to concussions.  The University of Kansas Medical Center is conducting the phase 2 ground-breaking trial for Oxeia’s drug treatment, OXE103,  which could address the underlying pathology of concussion (mTBI). The program seeks qualified volunteers from the Kansas City area to participate in this study which could help people with continued symptoms after sustaining a concussion.  Those interested in the greater Kansas City area interested in participating in the study should visit www.restisnotenough.com.

[1] https://www.uofmhealth.org/conditions-treatments/brain-neurological-conditions/concussion-athletes-neurosport

[2] https://traumaticbraininjury.net/2013/01/14/boxers-and-brain-injuries-a-scary-study/

The Silent Epidemic of Invisible Injuries: Domestic Violence and Traumatic Brain Injury

When you hear the term “traumatic brain injury,” or TBI, you might immediately think of common causes like car accidents, falling or a sports-related injury. Yet, there is another frequent cause of TBIs talked about far less: domestic violence. www.oxeiabiopharma.com

In a March 2022 report by the New York Times, Eve M. Valera, an associate professor of psychiatry at Harvard University and a leading researcher on traumatic brain injuries among survivors of domestic violence, estimated that while hundreds of concussions occur in the NFL each year, there could be nearly 1.6 million annual brain injuries among survivors of domestic abuse. 

This isn’t as surprising when you consider the epidemic of domestic violence. Statistics from the National Coalition Against Domestic Violence show that 1 in 4 women and 1 in 9 men will experience physical violence from their partner. Physical abuse isn’t the only form of domestic violence; emotional abuse, sexual abuse, and financial abuse are among the other ways that an intimate partner will exercise power and control. But physical abuse resulting in traumatic brain injury (TBI)  is frighteningly common. A paper published in the Journal of Aggression, Maltreatment & Trauma in 2019 predicted that upwards of 90% of all people that have a history of domestic violence have symptoms and signs of traumatic brain injury.

Acts of violence that can cause TBIs include hits to the face or head, hitting the head while falling or being shoved, and severely shaking someone (most often recognized in the incredibly dangerous “shaken baby syndrome”). Brain injury can also occur because of strangulation and oxygen deprivation, and as an estimated 50% of domestic violence victims are strangled at some point in the course of their relationship, often repeatedly.

On April 1, 2022, The Protecting Survivors From Traumatic Brain Injury Act was introduced by Senator Catherine Cortez Masto (D-Nev) and Senator Joni Ernst (R-Iowa). The legislation would require HHS to collect data every two years to better document the occurrence of TBI. The immediate goal is to help HHS in “understanding, addressing, and allocating resources to reduce and treat such injuries and the cause of such injuries”. Another important goal of the legislation is to ensure that providers get the training on TBIs so they can help connect survivors to the services they need. Most advocates receive training on trauma and safety planning and oppression, but we don’t have enough training in neuro knowledge or where the local neurorehabilitation services are.

In addition to recent media coverage on this issue, the overdue passage of the Violence Against Women Act (VAWA), and the introduction of The Protecting Survivors From Traumatic Brain Injury Act, there is also movement in the healthcare field.

In February 2022, a report by the National Academies of Sciences, Engineering, and Medicine (NAS) was published and calls for a new classification system for traumatic brain injury. The report criticizes the current system of classifying TBI as either “mild, moderate, or severe” stating that it is outdated and that this diagnosis should be based on the Glasgow Coma Scale, neuroimaging results, and blood biomarker results.

The NAS report also calls for the formation of a national TBI task force to create the framework and plan to improve the treatment of TBI.

There are no effective pharmacological FDA-approved treatments for head injuries and there is a dearth of research into TBI and domestic violence. We need Congress to support research focused on female IPV victims with head injuries, better data collection and sharing of data so that we understand the full impact of brain injury on all IPV victims and can respond with effective population- and culturally-specific programs for prevention, education, support services and treatment programs. 

Please contact  your senators to impress upon them the need to focus more resources to identify, reduce and effectively treat TBIs in domestic abuse survivors.

Note: For survivors, if you are concerned for your safety or would like to speak with someone about a relationship where you do not feel safe, the National Domestic Violence Hotline is available 24/7 at 1 (800) 799-SAFE; you can also text START to 88788 or chat with someone at their website www.thehotline.org.

Suzanne Dubus is the CEO of the Jeanne Geiger Crisis Center and has led the organization since 1997.  Throughout her career, she has advocated for survivors of domestic violence through programming, innovative approaches, collaboration, policy issues, and systems change. Suzanne was named a Champion of Change by the White House in October 2011. The Geiger Institute was created to help communities prevent domestic violence homicides.

Michael Wyand, DVM, PhD, is the CEO of Oxeia Biopharmaceuticals. Oxeia is conducting Phase 2 human clinical studies for its therapeutic drug, OXE-103, to treat concussions.  www.oxeiabiopharma.com

Oxeia Video Series - Concussion: More About the Unmet Medical Need to Treat Concussions - Part 3

Kartik Shah, Director and Co-founder of Oxeia Biopharmaceuticals talks more about the unmet medical need for effective treatments.

Oxeia Video Series - What is Oxeia?

Oxeia co-founder Kartik Shah talks about Oxeia, how it was started and the people behind the company.

Mountains were moved to develop Covid-19 vaccines. Can the U.S. Military do the same to find a treatment for concussions?

Shock and awe is one way to describe reactions to pharma’s achievement in bringing vaccines to market to combat coronavirus with unprecedented speed.  The availability of nearly limitless funds, well-orchestrated coordination among key players and a genuine sense of urgency propelled one of the greatest medical achievements of our times.  The old drug development paradigm has been transformed; the medical and pharma community is now reevaluating ways to drive innovation faster and more efficiently.  Now is the time for our nation to do the same to help those suffering from concussions, a form of traumatic brain injury (TBI), that impacts countless active servicepeople and veterans, as well as civilians.  The military is ideally situated to drive this charge forward.

Concussions, also known as mild traumatic brain injury (mTBI), are the most common type of TBI for members of the military. Now recognized as an epidemic, mTBI has become one of the highest priorities in public health because of its tremendous costs and possible long-term consequences. These “signature injuries” of the Iraq and Afghan conflicts are very real to active servicemembers, veterans and their families. The Department of Defense reported 430,000 head injuries among active-duty military between 2001 and 2018 with the vast majority ­82% – classified as mTBI.

Finding treatments for these injuries is both a matter of urgent military readiness, as well as a moral obligation.

The government is keenly aware of the impact concussions have on service members and veterans.  Both the Department of Defense and the Veterans Administration have sponsored programs to enhance the understanding of what causes concussions, as well as identify treatments and recovery protocols for mTBI. The Senate and House National Defense Authorization Act for 2022 directs increased funding for brain injury research.   The Senate Arms Committee bill report calls for “robust” therapeutic research for all levels of brain injury as an item of special interest. 

Tapping military might is logical to advancing research and finding treatments for mTBI. I encourage the armed forces to not only continue doing what they are already doing, but also expand their efforts.  Our military has a special ability to get the job done.  Like the working committees formed to combat Covid-19, the military has the might to galvanize disparate groups of professionals to share research and resources to power ahead for solutions.  The private sector players, many of which are biopharma start-ups, will gladly welcome the leadership and support of our military.

Effective treatments for mTBI can also result in significant cost savings.  While symptoms disappear for most concussion sufferers within days or a couple of weeks, research indicates that almost 40% of mTBI patients have post-concussion symptoms (PCS) lasting more than three months.  A study examining recovery of PCS patients found only 27% of their population eventually recovered.

These often debilitating symptoms require ongoing physical, speech, cognitive, vision, occupational and/or drug therapies for our active military and veterans.   Studies have also linked mTBI with depression and PTSD, and repeated mTBIs with various neurodegenerative diseases.  For example, studies have shown that veterans with a history of mTBI have a 56% higher risk of developing Parkinson's disease within 12 years of their injury,

Many of these impairments can negatively affect readiness and job performance for active military and ongoing problems for employment, as well as for families and the larger community.

Progress toward a treatment for TBI to help our servicepeople and veterans will also be a boon to the public at large.  In the past couple of decades, awareness about the dangers of concussions has led to extensive news coverage of active and retired professional football players, and other athletes.  Today our citizens are more likely to realize that a slip in the bathtub or a car crash, can lead to injuries that are not seen by the naked eye.  The costs of treating concussion for the general public are already staggering.  The American Association of Neurological Surgeons puts annual direct and indirect costs of the full spectrum of TBIs – from mild to severe – are $76.5 billion.  Approximately 75% of all TBIs are mTBI.

As New York Senator Kristen Gillibrand remarked at a December 2017 Senate Armed Services Committee meeting; “If the military figures this out, then the rest of us can too.”

Michael Wyand, DVM, PhD, is the CEO of Oxeia Biopharmaceuticals. Oxeia is conducting Phase 2 human clinical studies for its therapeutic drug, OXE-103, to treat concussions. 

Oxeia Video Series - Concussion: The Unmet Medical Need - Part 2

Michael Wyand, CEO of Oxeia Biopharmaceuticals talks more about concussions and the unmet medical need for effective treatments.

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Oxeia Video Series - Concussion: The Unmet Medical Need - Part 1

Michael Wyand, CEO of Oxeia Biopharmaceuticals talks more about concussions and the unmet medical need for effective treatments.

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Oxeia Video Series - What is a Concussion? - Part 2

Michael Wyand, CEO of Oxeia Biopharmaceuticals, explains how concussions occur, what happens in the brain during a concussion and the symptoms of a concussion.

A friend and advocate for brain health, Oxeia supports Richard Sherman and other athletes making their mental health a top priority

We at Oxeia Biopharmaceuticals wanted to give Richard Sherman, his family and others close to him some time and space before reaching out following Richard’s interactions with his family and police on July 14th.

We are relieved that no one was harmed in the incident.  Our foremost concerns are for Richard’s mental health, overall well-being and his safety, as well as that of his family.  We understand and are encouraged that he is getting the help he needs.

Richard has been a positive force both on and off the field. In his role as a member of Oxeia  Biopharmaceuticals’ board of advisors for the past 5 years, we value the spotlight he has focused on the need for greater player safety, as well as the critical need for effective drugs to treat concussion symptoms and the underlying damage causing the symptoms. It is our hope that when ready, he can continue working with us to raise awareness about the concussion epidemic and its unmet medical need.

Research has shown that 35% of elite athletes deal with a mental health crisis. Because these elite athletes are so outstanding in their fields, we can forget that they pay a high price for their injuries and the ongoing competitive pressure to deliver peak performance, and may well be dealing with ongoing and persistent mental health issues.  We are seeing increasing numbers of professional athletes beset by mental health issues go public with stories of their struggles.

As a company that is working to find a cure to help the many people who suffer from ongoing symptoms of concussion, it is our hope that the overwhelmingly positive response from the media and fans to these athletes’ stories will help more athletes tune into their struggles and seek mental health care early on.

Oxeia Video Series - What is a Concussion? - Part 1

Michael Wyand, CEO of Oxeia Biopharmaceuticals, explains how concussions occur, what happens in the brain during a concussion and the symptoms of a concussion.

Protein Hormone OXE103 is being Tested as a Treatment for Acute Concussions: Could BioPharma Deliver us a Therapeutic this Decade?

Modern medicine may be able to revolutionize the treatment of concussions sometime soon.  Oxeia Biopharmaceuticals, and a handful of other innovators, believe they are close to delivering a concussion drug.  But with the cost of bringing a new drug to market is estimated to be more than $1 billion, small pharma – the drivers behind much of today’s new drug treatments – need help from the government and investors

The best advice doctors have been able to give concussion sufferers for centuries is “get some rest.” But a new crop of enterprising biopharmaceuticals don’t think that advice is good enough.  A small but dedicated cadre of companies is conducting extensive research and development into the science of brain injury and advancing therapeutics to address this important, but neglected for too long, condition.   That’s good news for athletes, soldiers, children, the elderly and anyone else who may get a concussion. 

As long as there have been people, people have been getting concussions.  Imagine around 800 BCE, at the ancient Olympic Games, a wrestler, boxer or discus thrower takes a serious blow to the head.  The athlete probably just walks it off and continues in the competition as he pushes for the best result possible.  The ancient Greeks were, in fact, aware of concussions at a basic level.   A medical journal called the Hippocratic Corpus describes a condition described as the “commotion of shaking of the brain.”  But there is not much our Greek athlete can do to help his discomfort.  Ice wasn’t even available to help the swelling. 

Over the course of around 3,000 years, the mystery behind concussions is slowly revealed.  New theories emerge in the 10th century, more in the 13th century and then pace of research progresses, but still at a snail’s pace in the 18th,19th and 20th centuries.  But it isn’t until present day, with the help of tools like functional imaging and ion-channel function that modern scientists can elucidate what has confounded medics for so long.

Adding to the wait for a treatment, concussions weren’t always at the top of the must-be-studied medical conditions list.  So many other maladies and illness have taken precedence in modern times. Pharmaceuticals largely put their resources elsewhere.   We have our present day gladiators, football players, largely to thank for finally bringing to full light the seriousness of this condition.  Around 2009 debate about concussions in sports like football became a hot topic among athletes, fans and even the United States Congress. Chronic Traumatic Encephalopathy (CTE), a neurodegenerative disease caused by repeated head impacts, including concussions, has become part of the national conversation as it continues to be diagnosed after death in over 90% former NFL players studied. 

Between 1980 and 2009, fifteen Phase 3 trials for moderate to severe TBIs were conducted by pharma companies without success. Ironically, it is not Big Pharma that is taking the lead in the race for a concussion, also known as a mild TBI (mTBI), treatment. In the past decade, a group of biopharmaceutical scientists and entrepreneurs heard the roar from athletes, parents, the military and others that something has to be done to help concussion sufferers.  A collection of smaller, lesser-known players like Brighton Biotech, Astrocyte Pharma, Karyopharm Therapeutics, ALSP Inc., Prevacus, and my company, Oxeia Biopharmaceuticals have spearheaded the most promising research in the field.  If all goes well, concussion sufferers could see relief in five or so years.

What causes concussions and how can Oxeia address the root problem?

A direct or an indirect blow to the head can cause a concussion. Widespread activation of brain cells throughout the brain result in a profound depletion of energy that makes the brain function.  On top of that, the rapid forceful movement of the brain during the impact stretches the brain.  This jarring and altercation causes a disruption in the brain and keeps valuable information from flowing between different areas of the brain.  Some of this damage can result in long-term effects if the body is not able to restore normal functions within two hours of the incident.

Oxeia has been actively researching and testing OXE103, a synthetic human ghrelin protein and an endogenous hormone.  Currently in Phase 2 trials, we are cautiously enthusiastic about treatments with OXE103 because it has been shown in numerous animal and laboratory studies to restore normal energy metabolism, increase appetite and reduce the toxic effects of reactive oxygen species that form in low energy states – all the things that need to be done to help restore the brain after a serious blow to the head.

OXE103 freely crosses the blood-brain-barrier and helps stabilize metabolic and energy brain dysfunction following a concussion.  OXE103 uniquely targets the hippocampus region of the brain, an area important for cognition and memory. 

Oxeia Biopharmaceuticals has two Phase 2 clinical trials underway.  One of these is with concussion patients who are experiencing significant symptoms within 28 days of their injury. The second is with patients from the emergency room who are treated within 24 hours of their injury. These two patient populations represent the majority of patients who suffer concussive head trauma.

Promise is on the horizon for future concussion sufferers.

The U.S. Centers for Disease Control and Prevention estimates that just under three million concussion patients visit U.S. emergency rooms annually. Other studies put the number much higher at five million, with as many as 2.4 million of these with mTBI.  But we are confident help is on the way.  Scientists at Oxeia and several other biopharmaceutical firms are working diligently to bring to market treatments that not only help anyone – whether they are a professional or amateur athlete, a soldier, or just a regular person who slips and falls – lessen the severity of their symptoms, but also affect the underlying pathology causing the symptoms

Quality research and testing takes time as does getting FDA approval of a drug.   Money can also be an issue for some of the smaller, entrepreneurial organizations which lack the deep pockets of big pharma to fund expensive research and testing efforts.  While we may be closer than ever to bringing a real, scientifically-proven treatment to market, the reality is it may take another five years, maybe more, before clinicians and coaches are armed with a therapeutic that can dramatically lessen the severity of concussions. 

We understand Oxeia is not alone in the race to find a treatment for concussions and we support the efforts of all the companies searching for a cure.  It’s critical that all interested parties – especially people who have suffered from concussions – help us not only to continue to raise awareness about the dangers of mild traumatic brain injury, but also to urgently press for effective treatments.  The entrepreneurial class of biopharmaceuticals to which Oxeia and others belong does not have the deep pockets or the established government connections to move the race for the cure along as swiftly as big pharma does.  We need investment from individuals, institutional investors and from the government to bring a treatment to market.  The sooner we get a reliable, proven treatments for concussions, the better for all of us.

Author:  Vishal Bansal

Dr. Vishal Bansal is the Director of Trauma Surgery at Scripps Mercy Hospital in San Diego, California.  While at University of California at San Diego, he discovered a treatment potential of OXE103 for concussions through his work on neurocentric axis and brain injury.  OXE103 is a synthetic form of the hormone ghrelin that is known for stimulating appetite.  Dr. Bansal is Co-Founder and Chief Scientific Officer of Oxeia Biopharmaceuticals, which has launched a phase 2 clinical trial of OXE103 as medication for concussion patients.