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Merck and Ridgeback’s oral antiviral halves COVID-19 risk of hospitalisation or death

The phase 3 study shows the risk was halved compared to placebo for patients with mild or moderate COVID-19

Merck

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics have announced that molnupiravir, an investigational oral antiviral medicine, significantly reduced the risk of hospitalisation or death at a planned interim analysis of the phase 3 MOVe-OUT trial in at risk, non-hospitalised adult patients with mild-to-moderate COVID-19.

At the interim analysis, molnupiravir reduced the risk of hospitalisation or death by approximately 50%. Of a group of 385 patients who received molnupiravir, 28 patients (7.3%) were hospitalised until Day 29 following randomisation. In comparison, of a group of 377 patients who received placebo, 53 patients (14.1%) were either hospitalised or died up until Day 29 following randomisation.

Up until Day 29, no deaths were reported in the group of patients who received molnupiravir, as compared to 8 deaths in the group of patients who received placebo.

Due to these positive results, recruitment for the study was stopped early at the recommendation of an independent Data Monitoring Committee and in consultation with the US Food and Drug Administration (FDA).

Merck plans to seek Emergency Use Authorisation in the US as soon as possible and to submit applications to regulatory agencies worldwide.

If authorised, molnupiravir could be the first oral antiviral medicine for COVID-19.

Robert Davis, chief executive officer and president, Merck said: “More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world.

“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,” he added.

Wendy Holman, chief executive officer of Ridgeback Biotherapeutics said: “With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed.

“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorised for use, can make a profound impact in controlling the pandemic,” she added.

Article by
Iona Everson

4th October 2021

From: Research, Regulatory

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