What is Covid-19 Oral Drug Molnupiravir: Latest News, Treating for Patients and Results

Covid-19 Oral Drug Molnupiravir showed that the antiviral drug resulted in statistically significant fewer hospital admissions, faster recovery time.

Covid-19 Oral Drug Molnupiravir

The COVID pandemic has now made new antiviral treatments a priority as the number of people being infected daily worldwide still exceeds 400,000 and the highly contagious Delta variant of the virus spreads rapidly.

Though several drugs have been repurposed to help patients with COVID-19, scientists are still looking to discover antivirals that are effective against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19.

Recently, researchers at the University of North Carolina at Chapel Hill reported molnupiravir as the first oral and direct-acting antiviral that is highly effective at reducing nasopharyngeal SARS-CoV-2 infectious virus and viral ribonucleic acid (RNA) levels.

Covid-19 Oral Drug Molnupiravir: Latest Updates

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). 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, Businesswire reports.

In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021.

“It continues to be critically important to advance potential antiviral treatments to address the devastating impact of COVID-19 globally,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “If successful, molnupiravir could help address the continued urgent need for therapeutics.”

“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, chief executive officer, Ridgeback Biotherapeutics. “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.”

What is Drug Molnupiravir?

Molnupiravir, an experimental oral drug, is being developed by American pharmaceutical companies Merck & Co and Ridgeback Biotherapeutics for treating non-hospitalised Covid-19 patients.

Earlier, Hetero Labs started a phase-III, comparative, randomised and multicentre clinical trial on mildly infected cases. The trial, conducted at dedicated hospitals sites across India, was aimed at evaluating the safety and efficacy of Molnupiravir plus standard of care (test arm) versus standard of care alone (control arm), in mild Covid-19 patients with a positive RT-PCR test and randomised within five days of onset of symptoms, according to PTI.

“Phase 3 Trial Demonstrates Statistically Significant fewer hospital admissions, faster time to clinical improvement and early negative SARS CoV-2 RT PCR with Molnupiravir treatment in mild Covid-19 patients compared to standard of care alone,” Hetero Labs said in a statement.

Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University and is being developed by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics. Since licensed by Ridgeback, all funds used for the development of EIDD-2801/MK-4482 have been provided by Wayne and Wendy Holman and Merck.

Molnupiravir - First oral and direct-acting antiviral

Molnupiravir is an experimental antiviral drug that is orally active and was originally developed for the treatment of influenza. Merck, known as MSD, developed molnupiravir in collaboration with Ridgeback Biotherapeutics. The drug is now being evaluated in Phase III clinical trial, the MOVe-OUT study, to treat non-hospitalized patients with laboratory-confirmed COVID-19.

Drug Molnupiravir Shows Promise

Molnupiravir is currently being tested in a global late-stage study by Merck and partner Ridgeback, with the trial data expected in the fall of 2021.

Hetero Labs, a Hyderabad-based pharmaceutical company, said on Friday that it has sought an emergency use nod from the local regulator for coronavirus disease (Covid-19) drug Molnupiravir, after interim data from a late-stage trial showed that the drug helped in reducing hospitalisations and also speed up the recovery in mildly infected cases of the viral disease, according to news agency Reuters.

Hetero Labs also said there was no mortality in both the above groups and adverse events were non serious, mild in severity and none of them led to the discontinuation of Molnupiravir. The most common adverse events which were seen during the trial were diarrhoea, headache and nausea, the company added.

Hetero said the late-stage trial of molnupiravir, conducted at Covid-19 dedicated hospital sites across India, looked at the drug’s efficacy and safety in patients with mild Covid-19. The data showed the antiviral drug resulted in statistically significant fewer hospital admissions, faster recovery time and early negative SARS-CoV-2 RT PCR results.

Overall, 202 individuals were included in the study and received at least one dose of molnupiravir or placebo between June 19, 2020, and January 25, 2021, at ten sites in the United States. Of these, seven patients stopped participating in the trial due to adverse effects and participant withdrawal.

The team isolated infectious viruses from 43.5% of nasopharyngeal swabs at baseline. On the third day, isolated infections decreased to 1.9% in patients who received the 800 mg dose molnupiravir, which was comparable to 16.7% of participants who were given the placebo.

Further, infectious virus isolation also decreased on the fifth day in patients given 400 or 800 mg molnupiravir. No patients in either of these groups were found to exhibit contagious virus levels, which was comparable to 11.1% of those receiving a placebo.

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