Oxeia Biopharmaceuticals Announces Clinical Advancement Of Concussion Treatment

Oxeia Biopharmaceuticals Inc., announces its acquisition of rights to SUN11031, synthetic human ghrelin, from Kinemed Inc. Oxeia will develop SUN11031 as OXE-103 to treat concussions and other acute neurotrauma.

"Ghrelin is a well-characterized molecule with pleiotropic neuroprotective properties that are applicable to concussions. With SUN11031 we are able to rapidly initiate Phase 2 clinical studies for concussion, saving years of development time and reducing capital requirements," said Dr. Mark Corrigan, Senior R&D Advisor to Oxeia Biopharmaceuticals.

SUN11031 maintained a strong safety profile across nine previous clinical studies totaling 345 patients. In the agreement Oxeia accesses all prior data including an open US FDA Investigational New Drug Application (IND) and clinical supply of SUN11031.

Chris Nowinski, Ph.D., CEO of the Concussion Legacy Foundation and Advisor to Oxeia Biopharmaceuticals commented, "From professional football to youth sports, concussions are a major health concern lacking effective treatments. Oxeia continues to show its leadership and commitment to developing a concussion treatment based in strong scientific rationale with the acquisition of this advanced ghrelin program."

Concussions induce a metabolic response within the brain resulting in an "energy crisis" as brain cells attempt to respond to the injury. Oxeia's lead program, OXE-103, uniquely targets the metabolic dysfunction and subsequent neurotrauma underlying acute concussion pathophysiology. Oxeia anticipates initiating Phase 2 studies for OXE-103 in concussion and additional neurological indications in early 2018.

According to the Centers for Disease Control, 2.8 million cases of traumatic brain injury are seen in US hospital emergency rooms every year, and up to 3.8 million additional concussions occur in sports and recreation, although most go undiagnosed. Further, the number of children age 19 and younger presenting to the emergency room with concussion from sports or recreation more than doubled from 2001 to 2012. These injuries, especially when they lead to post-concussion symptoms, can affect school, sports, and home life. As the consequences of concussions are becoming better understood, active concussion rehabilitation and treatment are needed.