Antiviral drug Molnupiravir: The next big thing for COVID-19 treatment?

Molnupiravir, an antiviral drug, reduced hospitalization or death by approximately 50% in non-hospitalized adult patients with mild-to-moderate COVID-19, according to findings from an interim analysis of the Phase 3 MOVe-OUT trial.¹

These results of the trial are an encouraging step in the quest of the scientific and the medical community in finding an optimal treatment for this disease. What was also promising in the interim results was that the drug was found to be effective even against variants like Delta and Mu.¹

The medication, if approved, could become the first oral antiviral medication for this disease.

Understanding Molnupiravir

Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that works by introducing RNA-like building blocks into the SARS-CoV-2 virus, the causative agent of the COVID-19 genome as it multiplies, creating numerous mutations, disrupting replication, and killing the virus.

Thus, Molnupiravir inhibits viral propagation through lethal mutagenesis by introducing errors catastrophe in the viral genome. Molnupiravir targets the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) the same way other nucleoside analogs do and mediates replication and transcription of the coronavirus genome.

MOVe-OUT study and the Profound impact of Molnupiravir

The MOVe-OUT trial (MK-4482-002) was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19, at least one risk factor associated with symptom developing five days prior to randomization and poor prognosis.

Patients with laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within 5 days of study randomization were included. At study entry, all patients were required to have at least one risk factor associated with the poor disease.¹

The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of Molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.

Globally, the Phase 3 part of the trial of the MOVe-OUT study was done, in more than 170 planned sites in countries such as Chile, Argentina, Guatemala Brazil, Canada, Colombia, France, Israel, Italy, Japan, Mexico, Poland, Russia, Egypt, South Africa, Spain, Germany, Sweden, Taiwan, Ukraine, the United Kingdom, Philippines, and the United States

The recently released results evaluated data from 775 patients who were initially enrolled in the phase 3 MOVe-OUT trial on or prior to Aug. 5, 2021.

Results from the interim analysis of phase 3 MOVe-OUT trial

The promising interim results that have been recently released showed

• Molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received Molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377). The efficacy was not affected by the timing of symptom onset or underlying risk factors.

•No deaths were reported in patients who received Molnupiravir in 29 days when compared to 8 deaths in patients who received placebo.

• Based on the participants with available viral sequencing data (approximately 40% of participants), Molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu.

• The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively).

• The incidence of drug-related adverse events was also comparable (12% and 11%, respectively).

• Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group (1.3%) compared to the placebo group (3.4%).

Major Implications for India

The game-changing interim results promise an addition of a powerful weapon in the armamentarium of medical practitioners standing in the frontline in this virus pandemic.

If approved, the FIRST oral medication will not just simplify the COVID-19 management reducing it to consumption of some pills post-exposure, but also the nature of the "pill" will bring this it a reasonable cost than other injectables which require hospitalization.

The expected course of the medicine will come in 40 pills where patients will have to consume 4 pills twice daily for 5 days.

To know more about Molnupiravir Click Here.

References

1.https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/