Antibody drugs appear effective. Now can we make enough of them? – STAT

The Covid-19 pandemic teaches one lesson, over and over: The virus is moving faster than we are.

That difficult message was driven home Wednesday evening with news that an antibody cocktail developed by the drug maker Regeneron the same cocktail used to treat President Trump reduced infected patients need to visit the doctor, virtually or in person, or go to the hospital by 57%.

Those are encouraging results and, if authorized, the cocktail could be an important tool in beating back the virus. But right now, there are only 50,000 doses available, a pittance in comparison with the number of infections across the country.

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It is deeply unfortunate that we head into fall without enough doses of this drug, Scott Gottlieb, the former commissioner of the Food and Drug Administration, tweeted after Regeneron released its news. Many of us were talking about this as early as March. Regeneron did extraordinary work to secure their own manufacturing, but we needed a concerted industrial effort to get the supply we needed.

Indeed, Gottlieb penned op-eds in the spring and summer calling for a government-backed effort to manufacture the antibodies in large volumes akin to the massive effort to develop experimental, and still unproven, Covid-19 vaccines. He reiterated that action needs to be taken now to accumulate sufficient supply to treat high-risk patients.

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Most people who get Covid-19 get better on their own, so to make a material difference in the pandemics toll, effective antibody therapies need to be given to a lot of people to help a few.

Elil Lilly has also seen encouraging results for its own antibody cocktail, but here too supply is limited.

The potential benefit of such treatments is huge if there were more doses and if the logistics of using them can be managed. Both Regenerons drug and Eli Lillys need to be given intravenously.

Regeneron received funding from the U.S. government to ramp up production, and it has announced a partnership with Roche to scale up manufacturing further. The company expects to be able to produce 300,000 doses in the coming months. (The dose is a lot of antibody: 2.4 grams. Many antibody drug doses are measured in milligrams.)

Lilly has said it anticipates being able to ship 100,000 doses of its single antibody if regulators clear it, and could produce as much as a million doses by the end of the year. But that means using a dosage 0.7 grams that is lower than the one that appeared most effective in its single-antibody trial (2.8 grams) or the dose that was used in a trial of a combination antibody, which appeared more effective.

The companies, in being able to make doses for as many people as they have, have moved mountains. But it will be not enough.

As with so many efforts to tame this pandemic, every victory is tainted by the approach of the next battle.

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Antibody drugs appear effective. Now can we make enough of them? - STAT