Merck and Ridgeback Biotherapeutics submitted Molnupiravir, an antiviral pill discovered by Emory University scientists, to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) on Oct. 11.
If approved, Molnupiravir will become the first orally administrable antiviral drug for COVID-19 treatment. Other antivirals being used for COVID-19 treatment, such as Remdesivir, have to be administered intravenously, limiting the ability to treat outpatients.
The company submitted the application after licensing Molnupiravir from Emory and conducted clinical trials that found the drug “significantly reduced the risk of hospitalization or death” after contracting COVID-19.
Molnupiravir was discovered by scientists at Drug Innovation Ventures at Emory (DRIVE), a nonprofit company funded and owned by the University that aims to discover drugs to treat infectious diseases. DRIVE CEO and Co-Founder George Painter led this initiative.
According to interim data of a phase three clinical trial published by Merck on Oct. 1, non-hospitalized patients who had “mild to moderate” COVID-19 symptoms and were treated with Molnupiravir were about 50% less likely to require hospitalization or die compared to patients who received the placebo.
The drug prevents the virus from making accurate copies of itself. The SARS-CoV-2 virus is composed of RNA, a molecular blueprint that instructs cells to make specific proteins. RNA is made up of four types of nucleoside bases and each type of virus has a unique identity based on the order of these four bases. Viruses use an existing RNA molecule as a template to synthesize new RNA that can infect other cells.
Molnupiravir is a molecule similar to a nucleoside so that it can masquerade as one and takes the place of a particular nucleoside during RNA synthesis. The viral RNA containing Molnupiravir becomes a faulty template, leading to a mutation. As more mutations accumulate, the virus is unable to function and eventually dies out.
Research on Molnupiravir at Emory predates the COVID-19 pandemic by several years. In 2014, Emory received a grant from the Defense Threat Reduction Agency to find a treatment against Venezuelan equine encephalitis virus (VEEV).
VEEV is transmitted from horses to humans via mosquitos. In humans, the virus causes severe infections that can lead to long-lasting neurological symptoms and even death.
Painter and his team studied molecule EIDD-1931, a known nucleoside analog, for its effectiveness against VEEV. They eventually modified the molecule to form EIDD-2801 (Molnupiravir) and found that it was effective against VEEV in mice models and influenza in ferrets. Other studies demonstrated its effectiveness against SARS and MERS viruses.
EIDD-2801 was approved for a clinical trial to treat influenza in 2019. When COVID-19 started to spread, Molnupiravir was tested against SARS-CoV-2 in mice models. The treatment’s effectiveness eventually allowed for clinical trials.
The FDA plans to hold a meeting regarding Molnupiravir’s EUA application on Nov. 30.
Painter did not respond to the Wheel’s requests for comment.