- Study showed improvement in concussion symptoms in participants receiving OXE103.
- OXE103 pilot Phase 2a trial shows strong potential as an effective treatment for concussion.
- The OXE103 responder rate was 85% vs. a baseline of 33%.
- OXE103 is first in class investigational drug to potentially treat underlying neuro-metabolic and axonal injury in concussion.
- There are currently few studies for and no effective pharmacological FDA-approved treatments for concussion.
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 the potentially game-changing results of a Phase 2a pilot study of OXE103 at the University of Kansas Medical Center (KUMC).
The study results suggest a potentially effective treatment for concussion which could change the lives of thousands that suffer from post-concussion symptoms for sometimes months and years after injury.
The investigator-led trial focused on treatment for subjects within 28 days of injury who were highly symptomatic at screening. This group is representative of the majority of concussion patients who do not seek treatment immediately following their injury. Twenty-one patients were enrolled in the Phase 2A study. Participants were given the choice of receiving OXE103 or the standard of care. Thirteen received OXE103 and 6 received standard of care only. Two did not complete the study.
Those receiving OXE103 were given treatment twice a day for 14 days. A robust treatment effect was observed across all study endpoints. The endpoints were reduction in symptom burden and improvement in quality of life. The OXE103 responder rate was 85% vs. a baseline of 33%.
The data were first presented by principal investigator, Dr. Michael Rippee of KUMC, at the American Congress of Rehabilitation Medicine (ACRM) at their annual conference on October 31, 2023 in Atlanta. “I am highly encouraged by the responses we saw from the trial. This could be an important step forward for the 20% or more of patients that have ongoing and often debilitating post-concussion symptoms,” stated Michael Rippee, M.D., associate professor of neurology at KUMC and principal investigator for the study.
Oxeia CEO, Dr. Michael Wyand noted that “Post-concussion sufferers have long-been a largely overlooked population. In this proof-of-concept open label study we saw robust treatment effect across all endpoints. With these results we are ready to undertake a larger, multi-center randomized trial to confirm these results.”
Others in the field also found the results highly encouraging. Founding CEO of the Concussion Legacy Foundation and an advisor to Oxeia, Dr. Chris Nowinski, PhD, noted that, “This promising initial data provides hope for so many fighting symptoms months or years after injury. Long-term symptoms after concussions are an enormous burden on patients.” Richard Sherman, former NFL corner back and Oxeia advisor, has long been an outspoken advocate for NFL football player safety. He remarked that “Scientific solutions are coming, but not fast enough for the millions of today’s concussions sufferers. This is an exciting development that more of us should support.”
ABOUT THE STUDY
The trial enrolled participants within 28 days of injury who were highly symptomatic at screening. The goal of this Phase 2a study was to reduce symptom burden with OXE103 treatment. Measures of cognition and balance were also tracked to provide objective assessment of recovery.
OXE103 is synthetic human ghrelin, an endogenous hormone. OXE103 freely crosses the blood-brain barrier and is now being tested in humans to potentially treat concussions by addressing underlying neuro-metabolic dysfunction and axonal injury. 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 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 Boston, MA, 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: http://www.oxeiabiopharma.com/