Oxeia Biopharmaceuticals, a clinical stage biotech company developing a drug treatment for concussion to address underlying neuro-metabolic dysfunction and axonal injury, has announced “game-changing” results of a Phase IIa 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 21 patients within 28 days of injury who were highly symptomatic at screening. The goal of the study was to reduce symptom burden with OXE103 treatment. Measures of cognition and balance were also tracked to provide objective assessment of recovery. This group is representative of the majority of concussion patients who do not seek treatment immediately following their injury.
Participants were given the choice of receiving OXE103 or the standard of care. Thirteen received OXE103 and six received standard of care only. Two did not complete the study. Those receiving the treatment 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% versus a baseline of 33%.
A closer look at the data
The data were first presented by Michael Rippee, Associate Professor of Neurology at Kansas University Medical Center and principal investigator for the study at the American Congress of Rehabilitation Medicine’s (ACRM) annual conference on 31 October 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 percent or more of patients that have ongoing and often debilitating post-concussion symptoms,” stated Dr Rippee.
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.
Oxeia CEO, Dr Michael Wyand, noted: “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-centre randomised 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, Chris Nowinski, said: “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.”