ODDS APPEAR STACKED AGAINST NEW COVID DRUG

Promising treatment faces huge hurdles with U.S. regulators

Over the past year, the United States’ arsenal of COVID-19 treatments has shrunk as new variants of the coronavirus have eroded the potency of drug after drug. Many patients are now left with a single option, Paxlovid. While highly effective, it poses problems for many people who need it because of dangerous interactions with other medications.

But a new class of variant-proof treatments could help restock the country’s armory. Scientists on Wednesday reported in The New England Journal of Medicine that a single injection of a so-called interferon drug slashed by half a COVID patient’s odds of being hospitalized.

The results, demonstrated in a clinical trial of nearly 2,000 patients, rivaled those achieved by Paxlovid. And the interferon shots hold even bigger promise, scientists said. By fortifying the body’s own mechanisms for quashing an invading virus, they can potentially help defend against not only COVID, but also the flu and other viruses with the potential to kindle future pandemics.

“It doesn’t matter if the next pandemic is a coronavirus, an influenza virus or another respiratory virus,” said Eleanor Fish, an immunologist at the University of Toronto who was not involved in the new study. “For all the viruses we’re seeing that are circulating now, there’s utility to using interferon.”

For all of its promise, though, the drug — called pegylated interferon lambda — faces an uncertain road to the commercial market. Regulators at the Food and Drug Administration late last year told the drug’s maker, Eiger Biopharmaceuticals, that they were not prepared to authorize it for emergency use. Eiger executives said part of the problem seemed to be that the clinical trial did not include a U.S. site, but rather only sites in Brazil and Canada, and that it was initiated and run by academic researchers, rather than the company itself.

The regulators suggested that only a large clinical trial conducted at least in part in the United States and with more involvement from the company would suffice, Eiger executives said, a scenario that would require several years and considerably more funding. An FDA spokesperson said disclosure laws prevented the agency from commenting.

Those barriers are indicative of problems that some experts worry are threatening the development of a wide range of next-generation COVID treatments and vaccines — products that may help address the ongoing toll from COVID and also give scientists a head start in preparing for the next pandemic.

As it stands, Eiger executives said they might seek authorization for the interferon shot outside of the United States. China, for example, has been looking for new treatment options.

Some scientists involved in the research expressed frustration that doctors could not already prescribe the shots. Despite vaccines and previous infections helping to contain the damage from the virus, COVID is still killing roughly 450 Americans daily.

“I think it is a crazy situation that we’re still here now, three years into the pandemic, and I have one drug that I can prescribe with confidence to people who are getting infected,” said Dr. Jeffrey Glenn, a virus expert and director of a pandemic preparedness initiative at Stanford University, who helped lead the study of the interferon shot. “We need more options.”

Glenn founded Eiger, holds shares in Eiger and sits on its board of directors, but no longer works for the company.