DOD Awards Agreement to Test Drugs to Treat PTSD
News release:
Point of Contact:
Carey Phillips
Public Affairs Specialist
U.S. Army Medical Materiel Development Activity
(301) 619-7056
E-mail: carey.a.phillips2.civ@mail.mil
FOR IMMEDIATE RELEASE
FORT DETRICK, Md. – The U.S. Army Medical Materiel Development Activity, a subordinate command of the U.S. Army Medical Research and Materiel Command, announced today the award of Defense Health Agency funds through the Medical Technology Enterprise Consortium that is under an Other Transaction Agreement with the USAMRMC, to the nonprofit research organization Cohen Veterans Bioscience to conduct Phase 2 testing of drugs for the treatment of military-related Posttraumatic Stress Disorder using an innovative trial design.
Between ten and fifteen percent of U.S. combat-deployed Service Members develop PTSD, which remains one of the most common major health conditions that occurs as a result of combat experience, second only to depression. Between 2001 and 2013, during Operation Enduring Freedom, Operation Iraqi Freedom and Operation New Dawn, nearly 120,000 incident cases of PTSD were reported.
Currently, only two drugs are approved by the U.S. Food and Drug Administration for the treatment of PTSD, although both are only modestly effective in treating military-related PTSD. Over the past 17 years, individual academic investigators and companies have not delivered alternative FDA-approved drugs. In response to this unmet need, the U.S. Army Medical Materiel Development Activity's Neurotrauma and Psychological Health Project Management Office stood up an acquisition program to focus on developing and delivering drugs to treat PTSD.
Historically, PTSD drug-treatment trials have not accounted for the complexity of PTSD, and have tested one drug at a time using traditional designs. The decision to pursue an innovative trial design was based, in part, on feedback from the 2017 Department of Defense PTSD State-of-the-Science Summit.
"One of the charges coming out of the PTSD State of the Science Summit was for us to stop using traditional clinical trial approaches of testing one drug in all people with PTSD. Instead, we will take into account the individual differences that result in PTSD symptoms and use a precision medicine approach, matching the right drug to the right patient, as part of future trial designs," said Dr. Kimberly del Carmen, health sciences product manager for the Neurotrauma and Psychological Health Project Management Office at USAMMDA.
In recent years, the FDA's Center for Drug Evaluation and Research has recognized the need for alternative approaches to testing drugs.
"In August, the FDA launched a new program to advance innovative clinical trial designs for drug development, so we're excited to be at the forefront of this paradigm shift," said del Carmen.
The PTSD State of the Science Summit, determined that a private/public partnership model for future work was needed due to the multiple stakeholders involved in addressing the treatment of the disorder and related conditions. The stakeholders include academia, industry, government, non-profit organizations and advocacy groups.
Cohen Veterans Bioscience will test at least two drugs simultaneously in an adaptive platform clinical trial.
One of the advantages of the Medical Technology Enterprise Consortium Other Transaction Agreement mechanism is the potential to bring in funding from other partners to accelerate the testing of additional drugs. This design includes the collection of a common set of pre- and post-treatment clinical and biological data points across all arms of the trial, as well as pre-determined decision criteria that allow for one or more specified aspects of the study design to be modified based on interim data.
"By studying multiple drugs at the same time and in this way, we increase the likelihood that we will be able to identify patients who are most likely to respond to specific treatments," said del Carmen. "This information can then be used in the next phase of drug testing to accelerate the delivery of alternative, more personalized treatment options to our Service Members and Veterans with PTSD."
The clinical trial is scheduled to start by the end of 2019 after drugs have been selected for testing. The results of this trial will identify a drug to move forward for Phase 3 testing starting in 2022, and will ultimately lead to an FDA-approved treatment for military-related PTSD.
About USAMMDA
As the premier developer of world-class military medical capabilities, the USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.