Tuesday, March 17, 2020

The Real Battle

In the last week, investors have largely focused on the government's efforts and ability to protect the economy from coronavirus pain. But this is a public health crisis first, and the news there continues to get worse. There are more than 5,800 confirmed cases in the U.S. and 97 deaths, according to Johns Hopkins data.  World-wide, the number of cases has surpassed 196,000, with nearly 7,900 deaths.
But there was even some hope on the health front Tuesday. Regeneron said it could start human trials for a Covid-19 treatment by early this summer. Barron's Jack Hough spoke with the Regeneron CEO Leonard Schleifer this morning. The executive offered some of the most hopeful news I've heard since the virus began its lethal spread. Here are excerpts from the interview: 
On the search for a Covid-19 drug:
You have a three-pronged approach. First, try to take existing drugs that may have been developed for other purposes and see if they will work for Covid-19. Second, give people a human antibody that can fight off infection until there are vaccines around. Third, get a vaccine so that the body can make these antibodies itself.

On using existing treatments:
You can break them into two broad categories. People are looking at antivirals. There are drug trials that I’m aware of with Remdesivir, a Gilead Sciences drug, which was tried with Ebola. The idea there is you interfere with the functioning of the virus. Another thing you can think about is, are there any drugs that can prevent the virus from wreaking havoc on the body? When the virus gets into the lungs, it causes this massive inflammation. Maybe, just maybe, if you control the inflammation, you’ll be able do something to prevent patients from needing a respirator, and make their fever go away.

That’s our drug, Kevzara. It was discovered at Regeneron and developed for rheumatoid arthritis with our partner, Sanofi. Its mechanism of action is that we have these inflammatory mediators in the body called cytokines, and one of the bad ones is interleukin-6, which causes lots of inflammation. This may be what’s causing some of the inflammation in the lungs. In China, as this epidemic started, there was a drug made by Roche Holding, known as Actemra, which blocks the function of the interleukin-6 receptor. They had rather impressive, albeit uncontrolled, data. They treated 21 people, and all of these people did very well. They all got out of the hospital. A majority improved their ability to breathe, and their fevers went away. People have also tried this drug in Italy, with reportedly good results.

There are only two drugs in this class currently available. One is Roche’s drug, and the other is our drug, Kevzara. We worked very rapidly to design a trial. We worked closely with the FDA, collaborated with Barda [Biomedical Advanced Research and Development Authority], got help from Gov. [Andrew] Cuomo in New York, and we put in place in record time a clinical trial to see if in fact this approach, blocking the inflammation, might be good.

On when a drug might be available:
If the drug is shown to work in hospitalized patients, we have lots of the drug on hand and can make much more. The best case is that people wouldn’t progress from let’s say needing a little oxygen to going on a respirator. If we all get sick at once, it could be a disaster because we won’t have enough intensive care beds. A drug like this could really slow down the number of people who needed really intensive respiratory therapy. This could go fairly quickly. There are unfortunately a lot of people in the hospital. If we can enroll the study quickly over the next month, you should know within a few weeks of treating people how they’re doing.

You can read more from Jack's interview with Regeneron's CEO here

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