BHR Pharma enrolls first 400 patients for BHR-100 pivotal trial for TBI

As communities in the United States gather in support of Traumatic Brain Injury (TBI) Awareness Day, BHR Pharma, LLC's SyNAPSe- clinical trial reaches an important enrollment milestone.

"Every year, millions of us come together in March to raise awareness for the need for better prevention, rehabilitation and treatments for TBI. Unfortunately, even with more than 75 clinical trials in the past 20 years, no drug treatment has been proven effective for the treatment of TBI," said Thomas W. MacAllister, JD, PhD, President & CEO of BHR Pharma who is joining the brain injury community on Capitol Hill today. "We are excited that on this awareness day we met our 400th patient milestone, bringing us one step closer to potentially having the first ever approved drug treatment for severe TBI. This is truly a critical month for the brain injury community and our clinical trial, not just in the United States, but worldwide."

The trial has enrolled the 400 patients needed for the interim analysis. The primary endpoint for the SyNAPSe trial is the Glasgow Outcome Scale (GOS) at six months post-injury. If the independent Data Safety Monitoring Board responsible for reviewing the study observes overwhelming efficacy from the results of the interim analysis on the first 400 patients, the board may recommend that BHR make an early submission to the FDA, potentially shortening the timeline for approval of the acute intravenous treatment BHR-100.

This year's Brain Injury Awareness Month theme is "Anytime, Anywhere, Anyone - Brain Injuries Do Not Discriminate." Each year, an estimated 1.7 million people sustain a TBI and it is a contributing factor to a third of all injury-related deaths in the United States. BHR Pharma supports the Brain Injury Awareness Month campaign and recognizes that brain injuries are a global problem and can affect anyone.

"While recent reports have focused on brain injury among athletes and military veterans, it can happen to anyone, anywhere and anytime - it happened to me as a result of a skateboarding accident," said Jacob Gebuhr, a brain injury survivor who was treated by Michael S. Turner, M.D. at the Goodman Campbell Brain and Spine in Indianapolis, IN and is currently a student at Purdue University. "Participating in the SyNAPSe- clinical trial gave my family and I hope during our most difficult time when we truly felt we had no options."

Building on promising results that suggest progesterone may help, BHR Pharma is conducting the only global Phase 3, multi-center trial for severe TBI designed to support worldwide regulatory submissions. There are more than 140 hospitals in 18 countries participating in the SyNAPSe clinical trial, with teams led by the top brain injury experts in the world.

The SyNAPSe study is evaluating the effectiveness of its proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective treatment for patients that have sustained a severe blunt head injury. Previous clinical trials, conducted in the U.S. and China, suggest that progesterone can improve outcomes for TBI victims. Both studies showed about a 50 percent lower mortality in the progesterone-treated group as compared to placebo. The Chinese study also showed a statistically significant functional improvement and the U.S. study showed a similar trend. The SyNAPSe- trial is designed with the intent of bringing an approved treatment to market.