KANSAS CITY AREA RESIDENTS ASKED TO PARTICIPATE IN PHASE 2 TRIAL OF OXE103
For Immediate Release
KANSAS CITY AREA RESIDENTS ASKED TO PARTICIPATE IN PHASE 2 TRIAL OF OXE103 FOR THE TREATMENT OF CONCUSSIONS
Qualified Kansas City area residents encouraged to take part in major study to help patients suffering from concussions/mild traumatic brain injury (mTBI)
Clinical trial is being conducted at University of Kansas Medical Center, Kansas City, Kansas
First in class investigational drug to potentially treat underlying neuro-metabolic and axonal injury in concussion
BOSTON, MA (December 21, 2021) – Oxeia Biopharmaceuticals Inc., a clinical stage biotech company developing a drug treatment for concussion to address underlying neuro-metabolic dysfunction and axonal injury is actively recruiting participants for its ongoing Phase 2 clinical trial of OXE103 at the University of Kansas Medical Center. OXE103 could advance treatment directly addressing the underlying pathology of concussion (mTBI). The program seeks qualified volunteers from the Kansas City area to participate in this study, which could help people with continued symptoms after sustaining a concussion.
The University of Kansas Medical Center was selected to conduct the ground-breaking trial for its innovative approach in the field of concussion research and treatment. Dr. Michael Rippee, an associate professor of neurology at KU Medical Center, Primary Investigator of the study and a neurologist at The University of Kansas Health System Center for Concussion Management, oversees the two parts of the Phase 2 study. Part A was initiated in 2020 and focuses on treatment for subjects within 28 days of injury who are highly symptomatic at screening. This part of the study does not include randomization and all enrolling subjects will be offered treatment with OXE103. Enrolling subjects in Part A will also have the option to choose participation in a non-treatment control group if they do not want treatment. Part B is now open to enroll participants who are newly injured and are within 24 hours of presentation to the Trauma Unit at The University of Kansas Health System. 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.
Michael Wyand, Oxeia’s CEO, says he is pleased to be working with the University of Kansas Medical Center and Dr. Rippee. “I couldn’t think of any place better to begin these important studies,” said Wyand. “We are really counting on Kansas City and the surrounding communities to help in what could be a game-changer for people who suffer from concussions. We encourage people who have been diagnosed with a concussion within the past 28 days and are experiencing symptoms to participate in this study.”
The concussion study is open to individuals who have been injured within the past four weeks and are between the ages of 18 and 60. Volunteers must attend in-person study visits and complete at home tasks. OXE-103 is self-administered via injection twice daily for two weeks. Women who are pregnant or seek to become pregnant are not eligible for this study. Individuals interested in participating in the study should visit www.restisnotenough.com.
Concussion 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, or even moderate to severe TBI. To date, there are few other studies aimed at these patients.
ABOUT THE TRIAL
Part A is enrolling patients within 28-days of injury who meet eligibility criteria. Part B of the trial is enrolling participants within 24 hours of presentation to the University of Kansas Health System Trauma Unit. Both populations will be followed through day 44. The goal of this Phase 2 study is to reduce symptom burden with OXE103 treatment. Measures of cognition and balance will also be tracked to provide objective assessment of recovery. Those interested in participating should visit: www.restisnotenough.com
About OXE103
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’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/
For further information, please contact:
Communications Strategy Group
Frank Pietrucha
fpietrucha@comstratgroup.com
+1 202 253 7376