News Release: Oxeia announces initiation of Phase 2 trial for OXE103
* Subsequent to the release sent on October 20, 2020, there has been an update regarding the Phase 2 Trial. There are now two arms of the study: Part A: Post-Acute (within 28 days of injury) and Part B: Acute (within 24 hours of injury). Part A has been adjusted and does not include randomization and all enrolling subjects will be offered treatment with OXE-103. Enrolling subjects in this Part A will also have the option to choose participation in a non-treatment control group if they do not want treatment. Part B participation includes double-blinded randomization to receive either OXE103 or placebo. There is no option to choose participation in a non-treatment control group.
For Immediate Release
OXEIA BIOPHARMACEUTICALS, INC. ANNOUNCES INITIATION OF PHASE 2 TRIAL FOR OXE103 FOR THE TREATMENT OF CONCUSSIONS
Randomized, placebo controlled, clinical trial is being conducted at University of Kansas Medical Center, Kansas City, Kansas
Enrolling highly symptomatic participants within 28 days of injury
First in class investigational drug to potentially treat underlying neuro-metabolic and axonal injury in concussion
Concussions now known to increase risk of lifelong neuro-degeneration
SAN DIEGO,CA (Oct. 21, 2020) – Oxeia Biopharmaceuticals Inc., a clinical stage biotech company developing a drug treatment for concussion to address underlying neuro-metabolic dysfunction and axonal injury, announced today initiation of a Phase 2 clinical trial of OXE103 for treating concussion. The Phase 2 clinical study is being conducted by Dr. Michael Rippee, an assistant professor of neurology at the University of Kansas Medical Center and a neurologist at The University of Kansas Health System, who specializes in concussion management and treating persistent, debilitating symptoms after injury.
This study is important in advancing treatment as OXE103 may directly address the underlying pathology of concussion. Concussions can lead to a lifetime of health issues, including chronic headaches, depression, problems with thinking and memory, vision and balance issues, and sleep disorders. However, concussions – and especially treatment for concussions – have not received the same level of attention that has been focused on chronic traumatic encephalopathy (CTE), or even moderate to severe traumatic brain injury (TBI). To date, there are few other studies aimed at these patients.
“We’re excited to be working with Oxeia in hopes of developing a treatment for people who have continued symptoms after sustaining a concussion, which can affect their quality of life and their ability to care for their homes, prevent them from driving and frequently impair their ability to work,” said Dr. Rippee. “We’re hopeful that this new treatment may not only (more) improve symptoms, but also might directly affect the underlying pathology causing the symptoms.”
Treatment with OXE103 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. OXE103 also has effects on the axonal wiring system of the brain, which improves information flow and increases the connections between nerve cells.
“The launch of this trial is an important milestone for OXE103 and the millions of people who continue to suffer daily as a result of a lack of effective treatment options,” said Dr. Michael Wyand, CEO of Oxeia. “We are very encouraged with our progress to date in finding an effective therapeutic to treat concussions and other acute neuro-trauma conditions and we’re looking forward to further advancements. It’s clearly evident that rest, the current standard of care for concussions, is not enough and that new clinical solutions are needed.”
According to the U.S. Centers for Disease Control and Prevention, almost three million patients with suspected brain injury visit the emergency room every year in the U.S. Another study puts the estimate at nearly five million. Almost one-half of these are diagnosed with a TBI and as many as 95%, or 2.4 million, presenting to the emergency department with suspected TBI have mild TBI.1 Additional studies suggest that as many as 50% of competitive sports and recreation related concussions alone go unreported.2 Although concussions are commonly associated with sports-related injuries, a significant number of concussions annually are from falls, workplace and motor vehicle accidents, military combat operations and training exercises. In 2014, falls were the leading cause (48%) of TBI-related ED visits.3 Research in the last two decades has increasingly linked concussions to neurodegenerative conditions including dementia, Alzheimer’s disease and CTE.
“These findings show that it’s critical that we find an effective and early treatment for concussion for the millions suffering from the long-term, life altering impacts of concussion,” stated Wyand.
ABOUT THE TRIAL
The trial is enrolling participants within 28 days of injury who are highly symptomatic at screening. Participants who meet eligibility criteria will be randomized 1:1 to treatment with OXE103 or placebo and followed through day 44. The goal of the study is to reduce symptom burden with OXE103 treatment. Measures of cognition and balance will also be tracked to provide objective assessment of recovery.
About OXE103
OXE103 is synthetic human ghrelin, an endogenous hormone. 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. Treatment with OXE103 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.
About the University of Kansas Medical Center
The University of Kansas Medical Center The University of Kansas Medical Center’s mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans.
About Oxeia Biopharmaceuticals
Headquartered in San Diego, CA, Oxeia Biopharmaceuticals is a privately held clinical stage biotech company developing drug treatments for concussion and underlying neuro-metabolic dysfunction. For more information, please visit: https://www.oxeiabiopharma.com/
For further information, please contact:
Communications Strategy Group
Ted Agne
edagne@comstratgroup.com
+1781 888 0099
Heather Conover
hconover@comstratgroup.com
+1508 789 9273
Frank Pietrucha
fpietrucha@comstratgroup.com
+202 253 7376
Oxeia Biopharmaceuticals:
Lindsey McClelland
lmcclelland@oxeiabiopharma.com
+1978 793 0800
Michelson, Edward A., MD, et. al. Emergency Department Time Course for Mild Traumatic Brain Injury Workup. July 2018; 19(4) 635-640. 10.5811/westjem.2018.5.37293
Harmon, Kimberly G. MD1, et. al. Clinical Journal of Sport Medicine Position Statement: Concussion in Sport January 2013 - Volume 23 - Issue 1 - p 1-18
https://www.cdc.gov/traumaticbraininjury/get_the_facts.html
