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Merck Reports Positive Data From Molnupiravir Phase 3 Trial In Mild Or Moderate COVID-19 Patients

Drug major Merck & Co., Inc. (MRK) and Ridgeback Biotherapeutics Friday announced positive interim analysis of Phase 3 MOVe-OUT trial of molnupiravir (MK-4482, EIDD-2801) in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19.

Merck said it plans to submit an application for Emergency Use Authorization or EUA to the U.S. FDA as soon as possible based on these findings. The company also plans to submit marketing applications to other regulatory bodies worldwide. If authorized, Molnupiravir could be the first oral antiviral medicine for COVID-19.

In pre-market activity on the NYSE, Merck shares were gaining around 5 percent to trade at $78.75.

In a statement, the companies noted that molnupiravir, an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the trial .

The planned interim analysis evaluated data from 775 patients who were initially enrolled in the Phase 3 MOVe-OUT trial on or prior to August 5, 2021.

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients.

Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.

At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration, recruitment into the study is being stopped early due to these positive results.

Wendy Holman, chief executive officer of Ridgeback Biotherapeutics, said, "With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed."

Further, the company said it has been producing molnupiravir at risk in anticipation of the results from MOVe-OUT. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.

Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the U.S. FDA.

The company has also entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.

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