A potential new treatment for COVID-19 still undergoing study cleared non-hospitalized coronavirus patients who had symptoms of infection faster than in patients who received a placebo, according to preliminary results newly released.
And it’s a pill.
If ongoing clinical trials continue to show similar positive results, it could be the first oral antiviral against COVID-19 to join a relatively small toolbox of treatments, potentially saving infected people from progressing to severe disease.
The only other treatment that has been approved by the U.S. Food and Drug Administration is remdesivir, a drug that’s delivered through the veins and limited to hospitalized COVID-19 patients ages 12 and up.
Results from the Phase2a study were presented at the 2021 Conference on Retroviruses and Opportunistic Infections on Saturday.
“The secondary objective findings in this study, of a quicker decrease in infectious virus among individuals with early COVID-19 treated with (the pill), are promising and if supported by additional studies, could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally,” Dr. William Fischer, lead investigator of the study and an associate professor of medicine at the University of North Carolina School of Medicine, said in a statement.
The pill, called molnupiravir, was randomly assigned in various doses among 182 participants across several medical centers who showed coronavirus symptoms within a week of testing positive and were not hospitalized.
By day five, no one who took the pill still tested positive for coronavirus, while 24% of those who got a placebo drug did, according to the study. Participants who took larger doses of the drug “also had lower levels of infectious virus than the placebo group after three days,” The Wall Street Journal reported.
The pill works by blocking the coronavirus’s ability to replicate. It was developed by Miami-based company Ridgeback Biotherapeutics and Merck, a multinational pharmaceutical company with its U.S. headquarters in New Jersey.
The researchers said there were no “safety signals” of concern. Four “serious adverse events” were reported, but none was caused by the pill.
“It’s tantalizing and interesting, but it’s not exactly 100% complete,” Dr. Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, who wasn’t involved in the study, told The Wall Street Journal. “What we need to confirm is that there’s clinical benefit.”
The researchers said the Phase 2 studies are ongoing, and they will provide updates when appropriate.
“We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” Dr. Wendy Painter, chief medical officer of Ridgeback Biotherapeutics, said in the statement. “At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”