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The still-experimental oral antiviral drug has been compared to Tamiflu but would be for COVID-19 not the flu.
Merck’s experimental antiviral drug showed a quick reduction in SARS-CoV-2 in a phase 2 study.
At day 5, there was a reduction in positive viral culture in subjects who received molnupiravir, an investigational antiviral agent, compared with placebo. None of the 47 study volunteers in the molnupiravir group have positive viral cultures where as six of the 25 (24%) of those in the placebo group did. This finding was a secondary endpoint of the study.
“The secondary objective findings in this study, of a quicker decrease in infectious virus among individuals with early COVID-19 treated with molnupiravir, are promising,” said William Fischer, the study’s lead investigator and associate professor of medicine at the University of North Carolina School of Medicine, in a press release from Merck and Ridgeback Biotherapeutics, a biotech start-up in Miami.
Molnupiravir is an oral antiviral agent. The Wall Street Journal described molnupiravir as “a kind of Tamiflu” for COVID-19.
The preliminary data was presented during the 2021 Conference on Retroviruses and Opportunistic Infections on March 6. Results from the treatment’s Phase 2/3 study are expected in May.
“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir both outpatient and hospital settings and plan to provide updates when appropriate,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
This multi-center Phase 2a study included 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection.
The primary efficacy objective was reduction in time to viral negativity measured by reverse transcriptase polymerase chain reaction (RT-PCR) analysis of nasopharyngeal swabs.
No safety concerns were identified, according to Merck. Of the four serious adverse events reported, none were considered to be study drug related.
At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data,” said Wendy Painter, chief medical officer of Ridgeback Biotherapeutics.
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