Adaptive platform clinical research trial design to expedite potential new treatments for veterans

WILMINGTON, N.C., PPD, Inc. (Nasdaq: PPD), a leading global contract research organization, has been awarded Defense Health Agency funds to support a five-year Research Project Award (RPA) to develop and execute an adaptive platform clinical research trial of drug interventions to treat post-traumatic stress disorder (PTSD). PPD will work with U.S. Medical Research Development Command (USAMRDC) U.S. Army Medical Materiel Development Activity’s (USAMMDA) Warfighter Brain Health Project Management Office (WBH PMO) to test the effectiveness and safety of at least two pharmacotherapeutic drug candidates for the treatment of PTSD in U.S. military active duty personnel and veterans.

The RPA is part of the Medical Technology Enterprise Consortium (MTEC) that is under an Other Transaction Authority with the USAMRDC. As an MTEC member, PPD supports ongoing efforts to expand and grow additional important public health research programs like PTSD for the Department of Defense and U.S. Army.

“PTSD is a major unmet medical need, particularly for the men and women who serve in the U.S. military,” said Stephen Peroutka, M.D., Ph.D., vice president and global therapeutic area head of neuroscience for PPD and former chief of neurology at the Palo Alto VA Medical Center. “Our adaptive platform trial will offer an innovative, cost-effective and much-needed approach to PTSD drug development, with an end goal of delivering efficacious drugs to treat this major unmet medical need. We appreciate and are honored to have this opportunity to support active duty service members and veterans in the effort to develop life-changing drugs for those who face this illness.”

The adaptive platform trial design PPD plans to utilize will provide the WBH PMO with increased efficiency and a streamlined development process for the clinical program. The trial design facilitates evaluating multiple experimental treatment options simultaneously, adding new treatments over time, terminating ineffective treatments and graduating promising treatments to the next stage of development.

The PPD neuroscience clinical and medical experts who will be responsible for the studies are former VA attending psychiatrists and physicians who have treated PTSD in active-duty service members and veterans. At the same time, the leader of PPD’s government and public health services team who oversees the company’s team of experts focused on this illness is a retired Army veteran who has direct experience with those who suffer from PTSD.

PTSD is a mental health condition that affects about 8 million American adults during a given year. Some people develop the disorder after experiencing or witnessing a life-threatening event, such as military combat, a natural disaster, a car accident or a sexual assault. The number of veterans suffering from PTSD varies by service era, but up to 30% of war veterans have had PTSD in their lifetimes, according to the VA’s National Center for PTSD. Currently, there are only two drugs approved by the FDA to treat PTSD, both of which were introduced nearly two decades ago.

About PPD

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 26,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit www.ppd.com.

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