MTEC partners with the U.S. Army to fund clinical trials for traumatic brain injury medications

In partnership with the U.S. Army Medical Research and Materiel Command (USAMRMC), the Medical Technology Enterprise Consortium (MTEC) is pleased to announce that Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), an international traumatic brain injury (TBI) initiative, has been awarded funds to conduct Phase 2 clinical trials to test and fully characterize multiple TBI drug candidates.

TBI is one of the most significant injury risks faced by service members during combat. Yet effective treatment options to reduce mortality and prevent long-term morbidity caused by TBI are lacking in both military and civilian medicine. Over 30 clinical trials for TBI have failed, prompting calls for a paradigm shift in the design of TBI Phase 2 trials. TRACK-TBI’s research seeks to address these concerns and identify promising drug interventions for TBI.

MTEC awarded project ceiling in the amount of $24,999,999 to TRACK-TBI and its regulatory-focused partner, the TBI Endpoints Development Initiative (TED). Research by both organizations will focus on identifying at least one promising TBI drug to advance to Phase 3 clinical trials for the treatment of moderate to severe TBI. TRACK-TBI and TED will use a flexible, precision medicine approach to address multiple hypotheses, from dose finding to down selection recommendation of a drug intervention.

Lester Martinez, MD, MPH, Major General (Retired), U.S. Army, President and Chairman of MTEC Board congratulated TRACK-TBI and TED on the award. “The TRACK-TBI and TED research initiatives will help to mitigate one of the most significant and deadly injuries faced by both warfighters and civilians. MTEC is pleased to be a part of their efforts to identify new treatment options for TBI,” Martinez stated.

MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Materiel Command. To find out more about MTEC, visit www.mtec-sc.org.