Is this antiviral a game changer, Oral Antiviral, molnupiravir

https://www.merck.com/news/merck-and-...

Merck and Ridgeback

Oral Antiviral, molnupiravir (MK-4482, EIDD-2801)

Positive Interim Analysis of Phase 3 Study

Significantly reduced the risk of hospitalization or death

During day 1 to 5 to 29 days

Phase 3 MOVe-OUT trial

At risk, non-hospitalized adults with mild-to-moderate COVID-19

A global Phase 3, randomized, placebo-controlled, double-blind, multi-site study

of non-hospitalized adult patients

Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States

Eligibility criteria

Laboratory-confirmed mild-to-moderate COVID-19

With symptom onset within 5 days of study randomization

All patients were required to have at least one risk factor

Molnupiravir group

Hospitalization or dead, 7.3% of patients
28 out of 385

No deaths

Placebo group

Hospitalization or dead, 14.1% of patients
53 out of 377

P is 0.0012

8 deaths

Data Monitoring Committee in consultation with Food and Drug Administration

Recruitment into the study stopped early

Due to these positive results

Merck, application for Emergency Use

Authorization in US

Other regulatory bodies worldwide

About the Results of the Planned Interim Analysis

Evaluated data n = 775

Recruitment 90% of 1,550 the intended sample

Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups;

Efficacy was not affected by timing of symptom onset or underlying risk factor

About 40% of participants had sequencing data

Molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu

Incidence of adverse event between groups

Molnupiravir group

Incidence of any adverse event, 35%

Drug-related adverse events, 12%

Subjects discontinued study therapy due to an adverse event, 1.3%

Placebo groups

Incidence of any adverse event, 40%

Drug-related adverse events, 11%

Subjects discontinued study therapy due to an adverse event, 3.4%

Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells,

but men enrolled in its trials had to abstain from intercourse or agree to use contraception.

Women of child-bearing age in the study could (not) be pregnant and also had to use birth control.

https://www.reuters.com/business/heal...

About Merck’s Efforts to Enable Access to Molnupiravir, if it is Granted EUA or Approval

Merck has been producing molnupiravir at risk.

Merck expects to produce 10 million courses of treatment by the end of 2021

Existing procurement agreement with the U.S. Government

Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government upon EAU

$700 per 5 day course (2 doses per day)

$1.2 billion purchase agreement for the

1.7 million 5-day treatment courses of molnupiravir


MOVe-AHEAD
A global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study,

evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households