- Merck (NYSE:MRK) and Ridgeback Biotherapeutics have announced that molnupiravir (EIDD-2801/MK-4482), their investigational oral antiviral agent against COVID-19, managed to speed up the time for the infectious agent to become negative in COVID-19 patients.
- The preliminary data from the Phase 2a study were presented at the 2021 Conference on Retroviruses and Opportunistic Infections included findings on one secondary objective.
- On day 5, there was a reduction (nominal p=0.001, not controlled for multiplicity) in positive viral culture in the molnupiravir (all doses) treatment arm compared to placebo: 0% (0/47) for molnupiravir and 24% (6/25) for placebo.
- There were no reports of safety signals, and out of the four serious adverse events, none were believed to be linked to the treatment.
- The multi-center U.S. study involved 202 non-hospitalized adults with COVID-19 symptoms within seven days with a confirmed active SARS-CoV-2 infection.
- The primary efficacy objective was the reduction in time to viral negativity as detected by reverse transcriptase-polymerase chain reaction (RT-PCR) analysis of nasopharyngeal swabs.
- The secondary objective was the reduction in time (days) to the negativity of infectious virus isolation in swabs using Vero cell line culture.
- The data for primary efficacy and safety endpoints and additional secondary objectives will be shared at a future medical meeting, the companies said.
- Molnupiravir, an orally available ribonucleoside analog that can inhibit the replication of SARS-CoV-2 can perform the role of Tamiflu for the flu, the Wall Street Journal reported citing infectious-disease experts. Some had, however, a word of caution due to the early nature of the findings.
- Carl Dieffenbach, a director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, who was not involved in the study noted: “It’s tantalizing and interesting, but it’s not exactly 100% complete, what we need to confirm is that there’s clinical benefit.”
- Earlier, it was reported that based on a uniquely-designed in vivo mouse model containing human lung tissue, a team of researchers at the University of North Carolina had found that molnupiravir could stop the SARS-CoV-2 replication and prevents its infection in human cells.