The third phase
Clinical trials of Regeneron's drug against COVID-19 have entered the final stage
Regeneron Pharmaceuticals has announced the start of the third phase of clinical trials of a cocktail of two antibodies with the working name REGN-COV2 as a drug to prevent the development of COVID-19 infection in people recently exposed to the SARS-CoV virus-2. The company is also currently conducting clinical trials of the same drug for its effectiveness in treating patients who have already developed an infection. Despite the fact that the tests have not been completed, the company managed to sign a contract with the US government for $ 450 million – on the production and supply of a large number of doses of the drug.
The drug, called REGN-COV2, is a combination of two antibodies that block the spike ("spike") protein of the coronavirus, which it uses to penetrate human cells. Scientists evaluated thousands of antibodies obtained from genetically modified mice and from humans, choosing from them the two most effective against the SARS-CoV-2 virus and at the same time not opposing each other. Regeneron has chosen the strategy of using a cocktail of different antibodies to minimize the likelihood that the effectiveness of the drug will significantly decrease if the virus mutates.
The company is moving to the final stage of the third stage of trials to determine whether its drug can prevent disease in people who have recently been exposed to the virus – for example, through contact with infected households. The company also conducts clinical trials on patients with an already developed infection. A total of 1,850 hospitalized and 1,050 non-hospitalized patients in the United States, Brazil, Mexico and Chile will participate in late-stage trials of the drug, with preliminary results expected this summer. The company conducts tests in collaboration with the American National Institute of Allergy and Infectious Diseases (NIAID).
Despite the ongoing research, Regeneron has signed a contract with the Office of Advanced Biomedical Research and Development of the United States (BARDA) of the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DoD) to supply a variety of preventive and therapeutic doses by the fall of 2020. The exact number of doses has not yet been determined. It is assumed that it can be from 70 thousand to 300 thousand therapeutic doses and from 420 thousand to 1.3 million preventive doses. If the trials are successful and the FDA authorizes the use of the drug, deliveries will begin immediately.
After signing the contract with the government, Regeneron shares rose by 1.4%. In total, they have already grown by 67% since the beginning of the year.
The contract was signed as part of the Operation Warp Speed program funded by the US government, aimed at accelerating access to vaccines and treatments to combat COVID-19. As part of the same program, the US government invested $ 1.6 billion in Novavax Inc to cover the costs of research, production and distribution of a potential vaccine against the new coronavirus.
Previously, Regeneron and Sanofi conducted a trial as a cure for COVID of the already existing drug "Kevzara" (sarilumab). It was assumed that this human monoclonal antibody against the interleukin-6 receptor, currently used for the treatment of rheumatoid arthritis, could improve the course of the disease in those patients with COVID-19 who require artificial ventilation. The assumption, however, was not justified, and the tests were curtailed.
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