The U.S. Department of the Health and Human Services (HHS) and the Department of Defense (DOD) jointly announced an agreement with Merck to support advanced development and large-scale manufacturing of the their investigational therapeutic MK-7110 to treat hospitalized patients with severe or critical COVID-19.
The investigational therapeutic is a promising first-in-class fusion protein and immune modulator. Immune modulators have the potential to minimize the damaging effects of an overactive immune response to COVID-19. This overactive response can contribute to the severity of the illness.
“Our agreement with Merck is the latest example of how industry and government are coming together under Operation Warp Speed to move potential therapeutics all the way from development through to manufacturing, enabling faster distribution,” said HHS Secretary Alex Azar. “More good news about COVID-19 therapeutics is constantly emerging, and President Trump’s commitment to supporting lifesaving therapeutics has already helped deliver hundreds of thousands of Operation Warp Speed-supported therapeutics to the frontlines.”
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, to provide approximately $356 million to Merck. This funding allows for development of MK-7110, including completing activities required to request Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), and for delivery of up to 100,000 doses of MK-7110 by June 30, 2021.
With this approach, doses will be packaged and ready to ship in the first half of 2021, in the event FDA determines MK-7110 meets the statutory criteria for issuance of an EUA. The federal government would allocate these doses to treat severe and critical COVID-19 patients using the same approach that has been used successfully to allocate limited supplies of other COVID-19 therapeutic treatments. The doses will be made available to the American public at no cost however, there may be costs associated with hospitalization.
Interim analysis of a Phase 3 clinical trial in September 2020 indicated that patients who received a single dose of the therapeutic had a 60 percent greater chance of clinical recovery than those who received a placebo. Preliminary analysis also showed that the treatment potentially reduces the risk of respiratory failure or death by 50 percent compared to the standard of care. The study is still ongoing.
About Operation Warp Speed (OWS):
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 57 FDA approvals, licensures or clearances. Learn more about BARDA COVID-19 Portfolio and BARDA’s COVID-19 Response.
About the JPEO-CBRND:
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.