Patient enrollment is reportedly complete for the SyNAPSE trial; a study that aims to evaluate the safety and efficacy of a new intravenous progesterone treatment in treating traumatic brain injury (TBI).
According to BHR Pharma LLC, if the efficacy of BHR-100, which is the company’s proprietary progesterone formulation, is supported by the study’s final data, it could be the first approved treatment for TBI.
A news release from the company notes that prior research suggests progesterone exerts a neuroprotective effect, protecting or rebuilding the blood-brain barrier, decreasing development of cerebral edema, down-regulating the inflammatory cascade, and limiting cellular necrosis and apoptosis.
The release also states that the study’s last patient was enrolled in the United States at the University of Iowa Hospitals and Clinics. The SyNAPSE has a total of 154 participating sites in the United States, Israel, Argentina, and 18 other countries in Europe and Asia.
Achieving the enrollment goal is a significant milestone, says Roland Gerritsen van der Hoop, MD, PhD, BHR Pharma chief medical officer, head of Global Research and Development. “The study now moves into its important final phase—patient follow up and data collection. We will continue to work closely with our sites to ensure that these activities are completed in full,” van der Hoop explains.
The release states that patients are evaluated at six months post-injury using the study’s primary endpoint, the Glasgow Outcome Scale (GOS). The study’s secondary endpoints are comprised of the GOS evaluation at three months post-injury, GOS-Extended and quality of life (SF-36) evaluations at three and six months post-injury, and mortality assessment at one month and six months post-injury. The study’s results are expected in 2014.
The company notes that the European Medicines Agency (EMA) granted an orphan medicinal product designation for treating moderate to severe TBI to BHR-100 in February of this year. The FDA also granted BHR-100 an Orphan Drug designation for treating moderate to severe TBI in 2009.
Source: BHR Pharma LLC