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Molnupiravir Antiviral Description
Molnupiravir (MK-4482, EIDD-2801) is an experimental oral antiviral developed initially to treat influenza at Emory University. Molnupiravir is an orally bioavailable form of a potent ribonucleoside analog that inhibits replicating multiple RNA viruses, including SARS-CoV-2, the causative agent of COVID-19.
Molnupiravir (MK-4482) consists of the nucleoside analog N4-hydroxycytidine. Molnupiravir has been evaluated against coronaviruses, including SARS-1, MERS-CoV. In addition, Molnupiravir is active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission.
Miami, Florida-based Ridgeback Biotherapeutics L.P., and its partner Merck, conducted a comprehensive nonclinical program to characterize the safety profile of molnupiravir, including assays such asBig Blue and PIG-a,which are designed to provide a robust measure of a drug or chemical's ability to induce mutations in vivo. In addition, animals were administered molnupiravir for more extended and higher doses (mg/Kg) than those employed in human studies. These studies' totality indicates that molnupiravir is not mutagenic or genotoxic in vivo mammalian systems.
The Phase 3 portion of the global MOVe-OUT trial studying molnupiravir in non-hospitalized adult patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes is underway. In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021.
"These data are promising, and we are pleased to be able to present the Phase 2 interim results for molnupiravir while we proceed with the Phase 3 portion of MOVe-OUT in non-hospitalized patients," said Wendy Holman, CEO, Ridgeback Biotherapeutics, in a press statement issued on Jul 12, 2021. "There remains a great need for a range of solutions for the pandemic, and we are hopeful that molnupiravir will play a role in helping patients."
"As the (COVID-19) pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the (SARS-CoV-2) virus from becoming infected with symptomatic disease," said Dr. Nick Kartsonis, SVP, vaccines, and infectious diseases, clinical research, Merck Research Laboratories, in a press statement issued on September 1, 2021.
The MOVe-AHEAD study is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of SARS-CoV-2, the virus that causes COVID-19, within households. Last updated on October 1, 2021.
Merck confirmed plans on October 1, 2021, to seek Emergency Use Authorization in the U.S.and regulatory agencies worldwide. If Authorized, Molnupiravir could be the first oral antiviral medicine for COVID-19.
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