STAT reports:

From the moment Covid-19 emerged as a threat, one approach to making drugs to treat or prevent the disease seemed to hold the most promise: They’re known as monoclonal antibodies.

Now, scientists are on the brink of getting important data that may indicate whether these desperately needed therapies could be safe and effective. Clinical trials involving a pair of antibodies developed by Regeneron Pharmaceuticals will read out early results in September. A separate effort from Eli Lilly could yield data later in the fall.

Despite experts’ eagerness to see the data, however, there remains a debate over just how significant a role any antibody treatment might play in changing the course of the pandemic.

“A lot of smart people who understand immunology and virology think antibodies will work,” said Robert Nelsen, an investor at ARCH Venture Partners who is invested in Vir Biotechnology, which will start tests of its own Covid-19 antibody study this month.

Scott Gottlieb, the former commissioner of the Food and Drug Administration, is less sure antibody treatments will be significant factors in bringing the pandemic under control. Even though the development efforts have been proceeding extraordinarily fast by normal standards, the U.S. has spent billions of dollars purchasing vaccines in advance, but has not done far less to shore up capacity for antibody drugs.

“We may have missed a window to scale the manufacturing of antibody drugs that could have been an important bridge to a vaccine and a hedge in the event vaccines are delayed or don’t work,” Gottlieb, a fellow at the American Enterprise Institute and board member for Pfizer and other health care companies, told STAT. “These drugs had the ability to perhaps meaningfully change the contours of this epidemic, and we just won’t have enough doses to realize that goal.” [Continue reading…]