A phase 2 clinical trial (NCT04558346) of ghrelin (OXE103; Oxeia Biopharmaceuticals, San Diego, CA) for treating concussions has been initiated. The compound being tested is a synthetic form of the endogenous hormone ghrelin and freely crosses the blood-brain-barrier. Ghrelin is thought to have potential to help stabilize metabolic and energy brain dysfunction following a concussion.
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 the ghrelin or placebo and followed through day 44. The study is aimed to reduce symptom burden with the ghrelin treatment. Measures of cognition and balance will also be tracked to provide objective assessment of recovery.
"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. Michael Rippee, assistant professor of neurology at the University of Kansas Medical Center and a neurologist at The University of Kansas Health System. "We're hopeful that this new treatment may not only improve symptoms, but also might directly affect the underlying pathology causing the symptoms."
"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, chief executive officer of Oxeia. "We are very encouraged with our progress to date in finding an effective therapeutic to treat concussions and other acute neurotrauma 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."
In animal and in vitro studies, ghrelin has restored normal energy metabolism, increased appetite, and reduced the effects of reactive oxygen species. Ghrelin is also thought to have effects on neuronal connectivity.
Adam M. Staffaroni, PhD; Elena Tsoy, PhD; Jack Taylor, BS; Adam L. Boxer, MD, PhD; and Katherine L. Possin, PhD
Cyrus A. Raji, MD, PhD; Somayeh Meysami, MD; and Mario F. Mendez, MD, PhD
Julio C. Rojas, MD, PhD