The PPD clinical research business of Thermo Fisher Scientific Inc., a world leader in serving science, has been selected by the Biomedical Advanced Research and Development Authority (BARDA) to implement the first BARDA-supported phase 2 platform clinical trial to investigate multiple therapeutic options for the treatment of ARDS.
BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
The 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, leads to high rates of death among hospitalized patients. Currently, no approved or licensed therapeutics are available to treat ARDS.
Comprehensive clinical and biomarker data on the ARDS patient population is the primary objective of the hypothesis-generating study. This will then be used to better inform future clinical studies and contribute to the development of targeted therapies for the syndrome.
Under this contract, the PPD clinical research business will implement a large phase 2 clinical trial over three years. The clinical trial – a randomized, double-blind, placebo-controlled, multicenter phase 2 platform trial – will evaluate the safety and efficacy of the three host-directed therapeutics at up to 60 US sites, enrolling 600 hospitalized adult patients with ARDS. The drug candidates in the study will be announced early this year (2024).
The 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, senior vice president and president, of clinical research, at 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 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.