Thermo Fisher’s hope to improve outcomes for ARDS patients

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).

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