Merck intends to pursue the US FDA emergency use authorisation for the drug, and file regulatory applications with global agencies
Merck and Ridgeback Biotherapeutics announced positive results for molnupiravir (MK-4482, EIDD-2801), their investigational oral antiviral medicine in treating Covid-19 patients.
The interim analysis of the Phase 3 MOVe-OUT trial showed that molnupiravir reduced around 50% risk of hospitalisation or death in at risk, non-hospitalised adult patients with Covid-19.
In the study, treatment using molnupiravir resulted in no deaths, compared to eight deaths in people who received placebo.
Merck intends to use the findings to pursue US FDA emergency use authorisation (EUA) soon and plans to submit marketing applications to other regulatory bodies worldwide.
Merck chief executive officer and president Robert Davis 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.
“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.”
Molnupiravir is an investigational, orally-administered potent ribonucleoside analogue that inhibits the replication of SARS-CoV-2, the causative agent of Covid-19.
The drug has shown activity in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission.
In addition, it has demonstrated activity against the most common SARS-CoV-2 variants, according to pre-clinical and clinical data.
Molnupiravir was created by Drug Innovations at Emory (DRIVE), a not-for-profit biotechnology company wholly owned by Emory University.
Merck is currently developing the drug in collaboration with Ridgeback Biotherapeutics, where both the companies would share the profits equally.
Ridgeback received an upfront payment from Merck and also is eligible to receive certain developmental and regulatory milestone payments.
Ridgeback Biotherapeutics chief executive officer Wendy Holman 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.
“Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”
In June this year, Merck signed a procurement agreement with the US government to supply 1.7 million courses of its molnupiravir to the US.