ARDS is a life-threatening lung condition with multiple causes, including severe pneumonia and sepsis due to bacterial and viral infections such as influenza and SARS-CoV-2, that leads to high rates of death among hospitalized patients. Currently, no approved or licensed therapeutics are available to treat ARDS.

The primary objective of the BARDA-funded, hypothesis-generating study is to gather comprehensive clinical and biomarker data on the ARDS patient population to better inform future clinical studies and contribute to the development of targeted therapies for ARDS. Under this contract, the PPD clinical research business will implement a large Phase II clinical trial over three years. The clinical trial – a randomized, double-blind, placebo-controlled, multicenter Phase II platform trial – will evaluate the safety and efficacy of the three host-directed therapeutics at up to 60 U.S. sites, enrolling 600 hospitalized adult patients with ARDS. The drug candidates in the study will be announced in early 2024.

The PPD clinical research business will support the clinical trial with its deep capabilities and expertise in end-to-end platform clinical trials, seamless biomarker testing, and critical care, drug depot and laboratory services.

“There is an urgent, unmet medical need to better understand the clinical and biological features of ARDS to best treat people suffering from this often life-threatening condition,” said Sebastian Pacios, M.D., senior vice president and president, clinical research, Thermo Fisher Scientific. “We are privileged to contribute our expertise and innovative solutions to the development of effective treatments for ARDS. This opportunity has the potential to improve the outcome of ARDS patient health in the United States and around the world.”

The PPD clinical research business has more than three decades of experience delivering clinical research services and has conducted studies on a global scale across all trial phases and a broad array of therapeutic areas. During the past five years, it has conducted more than 175 respiratory studies, involving more than 40,000 patients at more than 10,000 research sites around the world.

For over 30 years, the business’ dedicated government and public health services group has successfully delivered clinical research services to various agencies, contractors and nonprofits in both prime contractor and subcontractor capacities within full compliance of all federal contracting requirements. In the past five years, the PPD clinical research business has supported more than 450 government-funded projects, including full-service clinical trials, statistical and data coordinating centers, clinical site monitoring centers, regulatory management centers, and clinical research operations and management support programs for BARDA, multiple National Institutes of Health institutes and centers, the Centers for Disease Control and Prevention and the U.S. Department of Defense.

This project, awarded to PPD Development, LP, has been funded in whole with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50124C00001.