PPD Awarded US Army Study to Help Develop Post-Traumatic Stress Disorder Drugs

Rhea-AI Summary

PPD has secured funding from the Defense Health Agency for a five-year research project to develop drug interventions for post-traumatic stress disorder (PTSD). This project aims to test the safety and effectiveness of multiple pharmacotherapeutics for U.S. military personnel and veterans, utilizing an adaptive trial design to enhance efficiency in drug development. PPD emphasizes the urgent need for effective PTSD treatments, given the limited current options. The initiative aligns with the company's commitment to improving public health through innovative research.

Positive

• Awarded Defense Health Agency funding for a five-year PTSD research project.
• Utilizes adaptive platform trial design to enhance drug development efficiency.
• Focuses on addressing a significant unmet medical need for military personnel and veterans.

Negative

• None.

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.

This news release contains forward-looking statements. These statements often include words such as “expect,” “believe,” “project,” “forecast,” “estimate,” “target” and other similar expressions. Although we believe these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our actual financial results, and therefore actual results might differ materially from those expressed in the forward-looking statements. Factors that might materially affect such forward-looking statements include, but are not limited to, the fragmented and highly competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to keep pace with rapid technological changes that could make our services less competitive or obsolete; political, economic and/or regulatory influences and changes; and other factors disclosed under the “Risk Factors” section in our periodic reports filed with the Securities and Exchange Commission (SEC), including our latest Annual Report on Form 10-K and Quarterly Report on Form 10-Q, which is available on our website at https://investors.ppd.com or the SEC’s website at www.sec.gov. We assume no obligation and disclaim any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law.

The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210218005643/en/

FAQ

What is the purpose of PPD's Defense Health Agency funding?

The funding supports a five-year research project aimed at developing drug interventions for post-traumatic stress disorder (PTSD).

What innovative approach is PPD using for the PTSD trial?

PPD is employing an adaptive platform trial design, allowing for multiple treatment evaluations and streamlined development.

Who are the targeted participants for PPD's PTSD research?

The research targets U.S. military active duty personnel and veterans suffering from PTSD.

What is the significance of PPD's PTSD research funding?

It addresses a major public health need, as current FDA-approved PTSD treatments are limited and outdated.

How does PPD's experience contribute to the PTSD study?

The study is led by experts, including former VA psychiatrists and a retired Army veteran, ensuring relevant clinical insights.