Palm Beach, FL – August 9, 2024 – A concussion is a mild traumatic brain injury temporarily disrupting the brain’s normal function. Generally, concussions are induced by a blow or jolt to the brain. However, it may occur from a hit to the body, which produces a reflex force to the head. In falls, sports, and car accidents, concussions are primarily seen. Factors such as the increasing incidence of mild traumatic brain injuries, ongoing product development, and rapidly growing geriatric population are expected to enhance the global concussion market growth.  The global concussion market is primarily driven by the increasing incidence of mild traumatic brain injuries and a growing number of geriatric populations worldwide. According to a recent survey conducted by the University of Pittsburgh’s Brain Trauma Research Center, over 62,000 concussion injuries are sustained in high school contact sports every year in the U.S. Besides, the global incidence of TBI is equivalent to 10 million people annually, according to the World Health Organization (WHO). Therefore, the increasing prevalence of mild traumatic injuries is expected to provide a favorable push to the market to grow over the forecast period.  A report from Straits Research said that the global concussion market size, which was valued at USD 7.80 million in 2023, is expected reach USD 10.44 billion by 2032, growing at a 3.7 % CAGR during the forecast period. Factors such as increasing number of mild traumatic injuries cases to drive the concussion market growth.  Active companies in the biotech industry this week include: Oragenics, Inc. (NYSE: OGEN), Abbott (NYSE: ABT), Biogen Inc. (NASDAQ: BIIB), Pfizer Inc. (NYSE: PFE), AbbVie (NYSE: ABBV).

The Straits Research report continued: “Moreover, the rising geriatric population has significantly boosted the concussion market growth. This segment of the population is physically more prone to such brain injuries and thus quite evidently as there happens to be a rise in such injuries across regions. The increasing number of R&D activities aimed to improve the current insights on traumatic brain injuries is positively influencing the market growth…  scientists are researching ways to externally activate the inherent capacity of the brain to adapt and heal itself, a phenomenon called neuroplasticity… Such research advancements are expected to create further lucrative opportunity pockets and drive market growth.  North American held the largest concussion market share among all regions accounting for the largest revenue share in (recent years). The regional market dominance is owing to several factors that influence the adoption of key market products in this region. For example, the greater incidence rate of concussions due to road accidents and sports injuries in the continent, increasing support from state and federal government through various initiatives and awareness campaigns to make aware of concussion prevention, diagnosis, and treatment are some of such key drivers.”

Oragenics, Inc. (NYSE American: OGEN) Announces Concussion Drug, ONP-002, Successfully Clears FDA-Required Cardiotoxicity Testing –  Oragenics, Inc., a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, announced its lead candidate for treating concussion successfully completed a study that indicates ONP-002 does not cause cardiotoxicity. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. Prior to conducting a clinical trial, the U.S. Food and Drug Administration (FDA) requires pharmaceuticals to be tested on cardiac receptors to ensure that they do not show any causes of electrical malformations.

Oragenics conducted hERG (human Ether-à-go-go-Related Gene) ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with Charles River Laboratories. Like previous non-GLP hERG studies, inhibitory concentrations were greater than 10 micromolar. Based on Phase I ONP-002 clinical trial dosing and subsequent blood plasma concentrations, ONP-002 is expected to have a large cardiac safety margin, suggesting that ONP-002 treatment for concussion will not cause cardiac arrhythmia.

“We are pleased that ONP-002 has demonstrated a strong safety margin for the heart, enabling us to continue planning the Phase II trials. Safety remains our top priority, and we will continuously monitor all safety parameters throughout the trials,” stated Michael Redmond, President of Oragenics. “Furthermore, a Phase II study is being planned to further evaluate the drug in concussed patients.”

Concussion is a significant unmet medical need, with an estimated 69 million cases reported annually worldwide. Common causes of concussions include falls, motor vehicle accidents, and contact sports. According to the CDC, the total annual healthcare cost for nonfatal traumatic brain injuries (TBIs) exceeds $40.6 billion. This includes $10.1 billion covered by private insurance, $22.5 billion by Medicare, and $8 billion by Medicaid. Concussions have been associated with other neurological disorders, such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Additionally, post-concussion symptoms, which can occur in up to 20% of affected individuals, are linked to long-term disability.  CONTINUED… Read this full press release and more news for Oragenics at:  https://www.oragenics.com/news-media/press-releases

Other recent developments in the biotech industry of note include:

Abbott (NYSE: ABT) Commentary: Traumatic brain injuries (TBI), including concussions, are common, and not only within the sports world. An estimated 4.8 million emergency room visits per year can be attributed to TBIs, and roughly 40% of all concussions are caused by slips and falls.

However, there has never been an objective method of assessing patients suspected to have sustained these invisible injuries—until now.

The main hurdle to recovery is that these injuries are often undiagnosed or misdiagnosed. Previously, concussions and TBIs have been evaluated through methods such as CT scan, patient questionnaire, or a neurological exam, which, in some cases, are not empirical on their own. For a condition that impacts millions annually and poses short-term risk, long-term risk, and even death—objective testing used in tandem with these methods is crucial.

Biogen Inc. (NASDAQ: BIIB), Beckman Coulter, Inc. and Fujirebio recently announced a collaboration to potentially identify and develop blood-based biomarkers for tau pathology in the brain and to potentially clinically advance and potentially commercialize new tests for tau pathology in Alzheimer’s disease (AD). The development of tau-specific blood-based biomarkers that can measure a patient’s tau burden could provide critical insights into the underlying pathological processes of AD and may help advance the development of a new generation of therapies impacting tau pathology.

Through this collaboration, the companies will work to identify new blood-based biomarkers and advance known blood-based biomarkers for tau pathology in AD. The collaboration aims to develop and clinically advance new tools that measure brain tau pathology to potentially stratify patients or monitor treatment response in AD clinical trials. The collaboration has the potential to advance tau-specific blood-based biomarkers and diagnostic tools that could be used not only in clinical trials, but also in clinical practice to enable adoption of future therapies impacting tau pathology.

Pfizer Inc. (NYSE: PFE) recently reported financial results for the second quarter of 2024 and raised its full-year 2024 guidance for both Revenues and Adjusted diluted EPS.  The second-quarter 2024 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: “We are driving progress toward our 2024 strategic priorities through solid execution across the company. I am pleased with the strong performance of our product portfolio in the second quarter led by several of our acquired products, key in-line brands and recent commercial launches. Notably, we achieved exceptional growth in our Oncology portfolio, with strong revenue contribution from our legacy-Seagen products.  Overall, I am encouraged by our performance in the first half of 2024 and we remain focused on making a difference in the lives of patients as we continue to advance and strengthen our company.”

AbbVie (NYSE: ABBV) recently announced that it has completed its acquisition of Cerevel Therapeutics (NASDAQ: CERE). With the completion of the acquisition, Cerevel is now part of AbbVie.

“AbbVie’s acquisition of Cerevel strengthens our foundation in neuroscience and positions us to deliver sustainable long-term performance into the next decade and beyond,” said Robert A. Michael, chief executive officer, AbbVie. “Our new Cerevel colleagues share our commitment to deliver meaningful change for patients living with neurological and psychiatric conditions. We are excited to welcome the talented Cerevel team to AbbVie.”

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