Drug Treatment for Traumatic Brain Injury (DTTBI)

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Materiel Development Activity (USAMMDA) technology objectives. Military relevance is a critical component of proposal submission. Strategic oversight for the award(s) supported by this RPP will be provided by the Neurotrauma and Psychological Health (NPH) Program Management Office (PMO) at USAMMDA.

Treating traumatic brain injury (TBI) remains one of the top priorities for the Department of Defense (DoD). The DoD and the military services require solutions to fill the capability gap to treat TBI as close to point of injury as possible, to reduce primary and secondary brain damage. The current standard of care for TBI remains supportive in nature, based on management of symptoms, with no drug therapies that address the brain damage. Despite numerous clinical trials on potential therapies, there is no U.S. Food and Drug Administration (FDA) approved drug therapy for the treatment of TBI. TBI has been shown to increase long-term mortality and reduce life expectancy. Estimated economic costs of care for TBI are >$75B per year according to the Centers for Disease Control (CDC). Therefore, it is important to develop a therapy that will decrease lost duty time and mitigate the life-long disability and rehabilitation costs associated with these post-injury conditions.

The intent of the DoD Drug Treatment for TBI (DTTBI) program is to improve the quality and quantity of candidate drugs entering Phase 3 trials for the treatment of moderate to severe TBI. The objective of this award is to leverage the capabilities of an existing clinical trial network with proven capability to recruit individuals with TBI, and to enable a TBI clinical consortium that can rapidly execute multiple FDA regulated Phase 2 clinical trials intended to fully characterize drug candidates prior to entering Phase 3 trials.

The deliverable at the end of the award is to demonstrate efficacy of at least one TBI candidate drug in Phase 2 clinical trials and recommend its continued development toward FDA regulatory clearance.

Scope of Work

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.