The pharmaceutical company Merck announced this Friday that the experimental pill it is developing against Covid-19, molnupiravir, reduces the risk of hospitalization and death by almost half, according to the data of a clinical trial that is being carried out. In fact, a team of independent experts who have overseen the trial recommended that it be stopped early due to positive results from the trial, according to informs the Washington Post.
The company states in a press release that it will request an authorization for its emergency use in the United States as soon as possible. According to data handled by Merck, which has not yet been peer-reviewed or published in any scientific journal, molnupiravir is likely effective against known variants of the coronavirus, including the dominant and highly transmissible Delta. If so, we would be facing the first effective antiviral pill against Covid-19.
Since molnupiravir does not target the spike protein of the virus – the target of all current Covid-19 vaccines – which defines the differences between the variants, the drug should be just as effective as the virus continues to evolveaccording to Jay Grobler, head of infectious diseases and vaccines at Merck.
Instead, molnupiravir targets viral polymerase, an enzyme necessary for the virus to make copies of itself. It is designed to work by introducing errors into the genetic code of the virus. The data show that the drug is most effective when given in the early stages of infection, according to Merck.
The US drug maker tested its antiviral on nasal swab samples taken from participants in the drug’s early trials. Delta was not in wide circulation at the time of those trials, but molnupiravir was tested against laboratory samples of the variant that is behind the latest increase in hospitalizations and deaths from COVID-19.
Merck is conducting two phase trials III of the antiviral you are developing with Ridgeback Biotherapeutics: one for the treatment of COVID-19 and another as preventive. The company expects the first study to be completed in early November, according to Grobler. “The data could come sooner or laterThe research was presented during IDWeek, the annual meeting of infectious disease organizations, including the Infectious Diseases Society of America.
Phase III trials
The interim analysis of the phase 3 ‘MOVe-OUT’ trial evaluated data from 775 patients who enrolled on or before August 5, 2021 to the study. At the time of making the decision to stop recruitment based on interim efficacy results, the trial was approaching full recruitment of the phase 3 sample size of 1,550 patients, with more than 90 percent of the predicted sample size already registered.
The eligibility criteria required that all patients had laboratory confirmed mild to moderate COVID-19, with onset of symptoms within 5 days of randomization of the study. All patients had to have at least a risk factor associated with a poor course of the disease at the beginning of the study.
Molnupiravir reduced the risk of hospitalization and / or death in all key subgroups; efficacy was not affected by the time of onset of symptoms or the underlying risk factor. Also, based on the participants with available viral sequencing data (approximately 40 percent of the participants), molnupiravir demonstrated consistent efficacy against Gamma, Delta, and Mu variants.
The incidence of any adverse events was comparable in the molnupiravir and placebo groups (35 percent and 40 percent, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12 percent and 11 percent, respectively). Fewer subjects discontinued study treatment due to an adverse event in the molnupiravir group (1.3 percent) compared to the placebo group (3.4 percent).
The phase 3 portion of the ‘MOVe-OUT’ trial was conducted worldwide, in over 170 centers in countries such as Germany, Argentina, Brazil, Canada, Chile, Colombia, Egypt, Spain, United States, Philippines, France, Guatemala, Israel, Italy, Japan, Mexico, Poland, United Kingdom, Russia, South Africa, Sweden, Taiwan and Ukraine.
Molnupiravir, administered orally, is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. The drug was invented at Drug Innovations at Emory (DRIVE), a non-profit biotechnology company wholly owned by Emory University, United States, and is being developed by Merck in collaboration with Ridgeback Biotherapeutics.
The drug is also being evaluated for post-exposure prophylaxis in ‘MOVe-AHEAD’, a global phase 3, multicenter, randomized, double-blind, placebo-controlled study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 in homes.
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