Advancement of Drugs for the Treatment of Repeated Mild Traumatic Brain Injury (mTBI)

Purpose

The intent of this jointly funded Request for Project Proposals (RPP) by MTEC and BrightFocus Foundation (BF), issued by MTEC, is to enable the advancement of candidate drugs into human clinical trials for the treatment of repeated mild traumatic brain injury (mTBI).

Scope of Work

Proposed projects should focus on tasks that support the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in support of a Phase 1 Clinical Trial. Examples of acceptable proposed project tasks include, but are not limited to:

• Development of a clinical trial protocol to be included in a regulatory submission.
• Manufacturing under Good Manufacturing Practice (GMP) and documentation required to support a regulatory submission.
• Manufacturing of the investigational product to be used in the clinical trial.
• Conduct of final animal tests required to complete the regulatory package.
• Compilation and completion of the regulatory package to be submitted to the FDA for the approval of a Phase 1 Clinical Trial.
• Onboarding and training of clinical site(s) in preparation for the execution of the clinical trial.

The deliverable at the end of the period of performance is the submission of an IND application by the Awardee for a Phase 1 clinical trial to the FDA.

Note: Through MTEC, the DoD U.S. Army Medical Materiel Development Activity (USAMMDA) has recently made an award and established a contractual relationship with a competent and experienced TBI Clinical Trial Network to enable the rapid clinical testing of several TBI drug candidates. The intent of this prior award was to establish an experienced and funded infrastructure that could be made available to drug sponsors/industry partners for the evaluation of candidate TBI drugs in Phase 2 clinical trials. The awarded Network brings 18 potential clinical sites and staff that are very familiar with TBI diagnosis, studies, and treatment. The already-awarded TBI Clinical Trial Network is now poised and ready to collaborate with several drug sponsors/industry partners to design and execute focused Phase 2 clinical trials on TBI drug candidates, with the goal to reduce the overall risk of future investment in a Phase 3 clinical trial for TBI. If the work from this MTEC-BF award is successful, Awardees may have the potential to transition into funded Phase 2 clinical trials by this TBI Clinical Trial Network downstream when appropriate.

Points of Contact

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