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Just days after it pulled the plug on its rheumatoid arthritis drug to treat COVID-19, biotech company Regeneron said on Monday it is starting Phase 3 of its double-antibody treatment for the novel coronavirus.
The Tarrytown, N.Y.-based Regeneron said it is evaluating REGN-COV2's ability to prevent infection in people who have yet to be infected with the virus, but have had "close exposure to a COVID-19 patient (such as the patient's housemate)." The study is being done in conjunction with the National Institute of Allergy and Infectious Diseases.
"We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic," said George D. Yancopoulos, M.D., Ph.D., co-founder, president and Chief Scientific Officer of Regeneron in a statement. "We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine."
The Phase 3 portion of the trial is being conducted at "approximately 100 sites" and the company is looking to enroll 2,000 patients across the U.S.
In addition, Regeneron noted that REGN-COV2 is also in the Phase 2/3 portion of testing to see if the cocktail can treat both hospitalized and non-hospitalized COVID-19 patients.
The congruent Phase 2/3 testing will be done with approximately 2,900 (1,850 hospitalized, 1,050 non-hospitalized) patients across the planet, including places in the U.S., Brazil, Mexico and Chile.
The U.S., Brazil and Mexico are three of the most impacted countries, with more than 2.8 million, 1.6 million and 256,000 COVID-19 cases, respectively. The U.S. and Brazil are the two most impacted countries, according to data provided by Johns Hopkins University.
The news comes after Regeneron and Sanofi said on Thursday that their jointly developed rheumatoid arthritis drug, Kevzara, failed to meet its primary endpoint in Phase III testing.
Currently, there is no known scientific cure for the disease known as COVID-19, however, a number of drugs are being tested to see if they can treat it.
In late June, Gilead Sciences said that its antiviral drug remdesivir, which has been granted emergency use approval in the U.S. and is approved in Europe and Japan, would potentially cost more than $3,000 in the U.S. for treating SARS-CoV-2.
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As of Monday morning, more than 11.47 million coronavirus cases have been diagnosed worldwide, more than 2.88 million of which are in the U.S.
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