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The story of what might become the next major breakthrough in COVID-19 treatment starts on a hotel hallway floor in January 2020, months before you were worried about the virus.
A scientist and a business executive were at a healthcare conference in San Francisco, hatching a plan to get a promising drug out of academia and into research trials for regulatory approval.
George Painter, president of the Emory Institute for Drug Development, and Wendy Holman, chief executive officer of Ridgeback Biotherapeutics, had met at the Handlery Union Square Hotel to discuss a compound Painter had started developing with funding from the National Institutes of Health.
Painter and Holman weren’t talking about targeting COVID-19 at the time. Rather, Painter was hoping his drug, molnupiravir, could get more funding to speed up flu studies. Holman was eager to see if it worked on Ebola.
That’s the thing about molnupiravir: Many scientists think it could be a broad-spectrum antiviral, effective against a range of threats.
A few days later, Holman arrived in Atlanta to see the labs at Emory and pore through the early data. As she and Painter hashed out the terms of a deal in which Ridgeback would buy the drug and start studying its safety and efficacy in people, COVID was seeping into the public consciousness.
By the time Ridgeback announced its acquisition of molnupiravir, on March 19, the world had shut down, and it was clear which threat the drug needed to be tested on right away.
Clinical trials for the pill kicked off in April. The next month, Merck & Co, which has a deep history of public-health development work, including on HIV and Ebola, struck a deal to buy rights to molnupiravir from Ridgeback and start the types of large-scale trials that could get it authorized by regulators. Those began in the fall.
Even as vaccines are rolling out worldwide, the coronavirus and its mutations still pose a major health threat. Drugmakers see an opportunity to add to the arsenal of potential therapies. Developers of molnupiravir hope the pills can be prescribed widely to anyone who gets sick.
The hurdle, beyond ensuring the drug works, is making sure it’s safe. Should Merck succeed in demonstrating that molnupiravir is effective and free of serious side effects, it could be a boon to the company, and to society, for many years to come.
The chemical compound on which molnupiravir is based—C9H13N3O6, or N4-hydroxycytidine—has been known for decades. It’s a nucleoside analogue. It interferes in replication, preventing a threat from causing severe infection. Molnupiravir doesn’t stop the virus from replicating, though; instead, the drug introduces errors into the virus’s RNA that are then replicated until it’s defunct.
With antivirals such as this, “basically you’re going to put a piece of sand in the gears and hope it stops the impact of the virus,” says Gomez, the former Niaid scientist. But, he adds, stopping the virus by creating errors in the genetic code or through other means can come with unintended consequences. “You don’t know where the sand might end up in the other parts of the body.”
Merck is considering studying molnupiravir as a preventive treatment, to be deployed after a person is exposed but before they’ve fallen ill. That would allow the drug to be deployed even more broadly in the fight against COVID-19.
If the drug proves safe and effective, Merck says it’s ready to go, with the capacity to make as many as 100 million molnupiravir pills, enough to treat 10 million people, by the end of the year.
Down the road, the drug could even be an asset beyond the fight against Covid. Painter says it’s shown promise against a number of RNA viruses, not just SARS-CoV-2, which would mean it could help governments prepare for the next pandemic. —Bloomberg
A scientist and a business executive were at a healthcare conference in San Francisco, hatching a plan to get a promising drug out of academia and into research trials for regulatory approval.
George Painter, president of the Emory Institute for Drug Development, and Wendy Holman, chief executive officer of Ridgeback Biotherapeutics, had met at the Handlery Union Square Hotel to discuss a compound Painter had started developing with funding from the National Institutes of Health.
Painter and Holman weren’t talking about targeting COVID-19 at the time. Rather, Painter was hoping his drug, molnupiravir, could get more funding to speed up flu studies. Holman was eager to see if it worked on Ebola.
That’s the thing about molnupiravir: Many scientists think it could be a broad-spectrum antiviral, effective against a range of threats.
A few days later, Holman arrived in Atlanta to see the labs at Emory and pore through the early data. As she and Painter hashed out the terms of a deal in which Ridgeback would buy the drug and start studying its safety and efficacy in people, COVID was seeping into the public consciousness.
By the time Ridgeback announced its acquisition of molnupiravir, on March 19, the world had shut down, and it was clear which threat the drug needed to be tested on right away.
Clinical trials for the pill kicked off in April. The next month, Merck & Co, which has a deep history of public-health development work, including on HIV and Ebola, struck a deal to buy rights to molnupiravir from Ridgeback and start the types of large-scale trials that could get it authorized by regulators. Those began in the fall.
Even as vaccines are rolling out worldwide, the coronavirus and its mutations still pose a major health threat. Drugmakers see an opportunity to add to the arsenal of potential therapies. Developers of molnupiravir hope the pills can be prescribed widely to anyone who gets sick.
The hurdle, beyond ensuring the drug works, is making sure it’s safe. Should Merck succeed in demonstrating that molnupiravir is effective and free of serious side effects, it could be a boon to the company, and to society, for many years to come.
The chemical compound on which molnupiravir is based—C9H13N3O6, or N4-hydroxycytidine—has been known for decades. It’s a nucleoside analogue. It interferes in replication, preventing a threat from causing severe infection. Molnupiravir doesn’t stop the virus from replicating, though; instead, the drug introduces errors into the virus’s RNA that are then replicated until it’s defunct.
With antivirals such as this, “basically you’re going to put a piece of sand in the gears and hope it stops the impact of the virus,” says Gomez, the former Niaid scientist. But, he adds, stopping the virus by creating errors in the genetic code or through other means can come with unintended consequences. “You don’t know where the sand might end up in the other parts of the body.”
Merck is considering studying molnupiravir as a preventive treatment, to be deployed after a person is exposed but before they’ve fallen ill. That would allow the drug to be deployed even more broadly in the fight against COVID-19.
If the drug proves safe and effective, Merck says it’s ready to go, with the capacity to make as many as 100 million molnupiravir pills, enough to treat 10 million people, by the end of the year.
Down the road, the drug could even be an asset beyond the fight against Covid. Painter says it’s shown promise against a number of RNA viruses, not just SARS-CoV-2, which would mean it could help governments prepare for the next pandemic. —Bloomberg
