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.