Why the odds are against a promising new Covid drug

New drug cancels all variants of coronavirus. But regulatory hurdles and a lack of funding make it unlikely to hit the US market anytime soon.

Over the past year, the America's arsenal of Covid treatments has dwindled as new variants of the coronavirus have eroded the potency of one drug after another. Many patients are now left with only one option, Paxlovid. Although it is very effective, it causes problems for many people who need it due to dangerous interactions with other drugs.

But a new class of variant-proof treatments could help replenish the country. arsenal. Scientists reported in the New England Journal of Medicine on Wednesday that a single injection of a drug called interferon cut a Covid patient's chance of hospitalization in half.

"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 see circulating right now, it's useful to use interferon."

For all its promise, however, the drug - called interferon pegylated lambda - faces an uncertain road to the commercial market. Late last year, Food and Drug Administration regulators told the drug's maker, Eiger Biopharmaceuticals, that they were not ready to clear it for emergency use. Eiger executives said part of the problem appeared to be that the clinical trial did not include a US site, only sites in Brazil and Canada, and was initiated and led by researchers. academics, rather than the company itself.

Regulators have suggested that only a large clinical trial conducted at least in part in the United States and with greater large company involvement would suffice, Eiger executives said, a scenario that would take several years and a lot more funding. An F.D.A. a spokeswoman said disclosure laws prevented the agency from commenting.

These hurdles are indicative of issues that some experts say threaten the development of 'a wide range of next-generation Covid treatments and vaccines - products that can help cope with the continuing toll of Covid and also give scientists a head start in preparing for the next pandemic.

As things stand, Eiger executives have said they may seek approval for injected interferon outside of the United States. China, for example, has been looking for new treatment options.

Some scientists involved in the research have expressed frustration that doctors cannot already prescribe the injections. Despite vaccines and previous infections helping to contain the damage of the virus, Covid still kills around 450 Americans a day.

"I think it's a crazy situation that we are still here now, three years into the pandemic, and I have a drug that I can confidently prescribe to those infected,” said Dr. Jeffrey Glenn, virologist and director of a preparedness initiative. the pandemic at Stanford University, which helped lead the study of the interferon sting."We need more options."

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