Posts tagged with "Testing has begun"

Merck’s little brown pill could transform the fight against COVID—and other viruses

March 26, 2021

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; weeks before you likely knew it existed, reports Bloomberg.

A scientist and a business executive were at a health-care 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, CEO 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.

They got so enthusiastic about the possibilities that their meeting ran long—and a group of lawyers kicked them out of their room. So they continued on the hall floor, hours after they had started.

Painter and Holman weren’t talking about targeting COVID at the time. The disease and the coronavirus that causes it, SARS-CoV-2, weren’t major concerns at the J.P. Morgan-run conference, where handshakes and cocktail parties with hundreds of guests were still the norm. 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 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, Bloomberg notes: Not everyone who is eligible for a shot will agree to get one. The hundreds of thousands of people who continue to contract COVID each day have few treatment options.

There’s no simple, inexpensive pill that can prevent those at the earliest stages of infection from later needing to be hospitalized. The monoclonal antibody therapies that doctors now have available for those most at risk of getting severely ill need to be administered by infusions at specialized medical centers. And for those who do become hospitalized, the antiviral remdesivir, from Gilead Sciences , speeds recovery, but hasn’t been shown to reduce deaths.

Drugmakers see an opportunity to add to the arsenal of potential therapies. There are 246 antivirals in development, according to the Biotechnology Innovation Organization, an industry trade group. And companies as big as Pfizer and as little-known as Veru  are testing them in pill form.

Bloomberg reports, Merck’s molnupiravir is among the furthest along. Its developers hope the pills can be prescribed widely to anyone who gets sick. Think Tamiflu for COVID.

The hurdle, beyond ensuring the drug works, is making sure it’s safe. Developers of antivirals have been dealing with the thorny issues they pose for decades. 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.

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.

Research contact: @Bloomberg