Concert and WRAIR enter CRADA to evaluate novel compound for seizure protection associated with TBI

Concert Pharmaceuticals, Inc. today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR). The CRADA will allow the WRAIR to conduct preclinical testing on a novel compound derived from Concert's DCE Platform™ (deuterated chemical entity platform) for seizure protection associated with traumatic brain injury (TBI), a major public health concern. This CRADA will further advance Concert's research program for drug compounds that have demonstrated anti-seizure activity in preclinical models and may be effective in the treatment of various epileptic or seizure-generating diseases and injuries, such as ischemic stroke and traumatic brain injury.

“We are pleased to collaborate with Dr. Tortella, a recognized leader in neurological research, to further evaluate this novel compound”

Under the terms of the CRADA, Concert and WRAIR will share costs on the preclinical efficacy evaluation of the novel drug compound developed using Concert's DCE Platform. The WRAIR will perform testing of Concert's compound using its relevant preclinical model of brain injury and lend its expertise in evaluating the compound's potential for treatment of brain diseases and injury.

"Our laboratory conducts basic and applied research aimed at the mechanisms and pathophysiology of brain injury, with a specific focus on developing improved diagnostics and novel neuroprotective therapeutics," said Dr. Frank Tortella, who will conduct the studies for this CRADA in his lab and who serves as Chief of the Brain Trauma Neuroprotection and Neuroplasticity Branch in the Center of Excellence for Military Psychiatry and Neuroscience at the WRAIR. "We look forward to collaborating with the Concert research team on the evaluation of this potential drug to treat brain injuries, an area of major interest to the WRAIR."

"We are pleased to collaborate with Dr. Tortella, a recognized leader in neurological research, to further evaluate this novel compound," said Roger Tung, Ph.D., President and Chief Executive Officer of Concert. "By working with organizations, such as the WRAIR, that have the resources and models to effectively evaluate our compounds, we believe we can most effectively identify and characterize lead drug candidates that may have the potential to treat important unmet medical needs such as TBI."

Concert is also collaborating with the National Institute of Neurological Disorders and Stroke's (NINDS) Anticonvulsant Screening Program to evaluate anti-seizure activity in a series of deuterium-modified compounds. This government-sponsored effort at NINDS is focused on preclinical testing of active drug compounds, through a series of in vivo and in vitro models, to define their potential as antiepileptic drugs.

TBI is a major public health problem occurring at a rate of over 1.4 million injuries per year in the United States, according to the Centers for Disease Control. It is of specific concern for military personnel deployed to Iraq or Afghanistan. According to the U.S. Department of Defense approximately 200,000 cases of TBI have been diagnosed in military service members over the past decade.