Merck (MSD) and Ridgeback Biotherapeutics have reported that their oral drug, molnupiravir (MK-4482, EIDD-2801), substantially lowered the hospitalisation or mortality risk in the Phase III MOVe-OUT clinical trial in adults with mild-to-moderate Covid-19.
The experimental antiviral medicine molnupiravir is an oral formulation of a ribonucleoside analogue that can potentially hinder Covid-19 causing SARS-CoV-2 virus replication.
The international, randomised, double-blind, placebo-controlled, multicentre Phase III trial analysed Covid-19 patients in the non-hospital setting with a minimum of one risk factor linked to reduced outcomes and the presence of symptoms in the five days before randomisation.
Analysing the oral antiviral’s efficacy versus placebo as evaluated by the percentage of subject hospitalisation and/or death from the randomisation time until day 29 was the primary efficacy goal of the trial.
The Phase III part was carried out globally, including in over 170 planned trial centres in nations including Argentina, Canada, Brazil, South Africa, the UK and the US, among others.
According to an interim analysis assessing results from 775 subjects, molnupiravir lowered hospitalisation or mortality risk by nearly 50%.
Furthermore, nearly 7.3% in the molnupiravir arm were in hospital or died by day 29 as against 14.1% in the placebo arm.
No cases of mortality were observed in the molnupiravir group versus eight in the placebo group through day 29.
According to the Independent Data Monitoring Committee’s (IDMC) recommendation and discussions with the US Food and Drug Administration (FDA), enrolment will be halted at an earlier time point on obtaining positive data from the trial.
Merck shortly intends to seek Emergency Use Authorization (EUA) from the FDA and marketing approvals from other drug regulators globally.
Merck CEO and president Robert Davis said: “With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most.
“Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”
In August, Merck started a rolling submission to Health Canada for molnupiravir as a potential Covid-19 therapy.