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How Good Is Gilead's Latest News for Coronavirus Drug Remdesivir?

By Keith Speights - Apr 14, 2020 at 7:03AM

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The big biotech reported some encouraging results for its antiviral drug. But it's still too early to get excited.

Unfortunately, there hasn't been very much good news so far in the battle against novel coronavirus disease COVID-19. The number of cases of the disease and deaths resulting from it continue to climb across the U.S. and in many countries. 

But there now could be at least a glimmer of light. Gilead Sciences (GILD 0.89%) recently announced initial results from an analysis of remdesivir in treating COVID-19 patients under a compassionate-use program were published in The New England Journal of Medicine. Just how good is Gilead's latest news? 

COVID-19 pill

Image source: Getty Images.

Some good news -- but it's still early

If you're the kind of person who sees a glass of water as half empty, you'll probably think that the results that Gilead announced were disappointing. The biotech stated that 47% of patients were discharged from the hospital after being treated with remdesivir. That means that more than half of the patients remained hospitalized.

However, there's a lot more to the story. First of all, the patients included in the analysis were critically ill. Nearly two-thirds of them were on mechanical ventilation. Well over half of these patients were extubated after receiving remdesivir and could breathe on their own. That's certainly encouraging.

On an overall basis, 68% of patients had an improvement in oxygen support class within 18 days after their first dose of remdesivir. Within 28 days, 84% of patients in the analysis demonstrated clinical improvement. It's not surprising that clinical improvement was more frequent in patients on noninvasive forms of ventilation than in patients in the worst shape who were on invasive ventilation.

Keep in mind that the analysis published in The New England Journal of Medicine included only 53 patients and wasn't a controlled study. 

Jonathan D. Grein, director of hospital epidemiology at Cedars-Sinai Medical Center and the lead author of the published article, stated, "We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful." Gilead Sciences CEO Daniel O'Day also acknowledged in an open letter that the analysis was limited and that the results were "of the greatest significance for the patients whose symptoms improved."

A lot going on

Remdesivir is at the center of significant activity. Seven clinical studies evaluating the drug in treating COVID-19 are in progress.

China initiated the first two clinical trials of Gilead's drug in February. However, O'Day stated that one of those studies targeting patients with severe cases of COVID-19 has been stopped because of "stalled enrollment." 

A large clinical study of remdesivir including around 800 patients with COVID-19 is being conducted by the U.S National Institute of Allergy and Infectious Disease (NIAID). The World Health Organization (WHO), which referred to remdesivir in February as the "one drug right now that we think may have efficacy," has a global clinical study under way. 

The U.S National Institute of Allergy and Infectious Disease (NIAID) began a global trial on February 21. This trial randomly assigns patients to treatment with either remdesivir or with a placebo to enable a controlled comparison of outcomes. The trial is enrolling approximately 800 patients with a broad spectrum of symptoms. French public health organization Inserm also recently launched a clinical study of remdesivir.

Gilead is conducting two late-stage studies of its own. One of the studies focuses on patients with severe cases of COVID-19 while the other targets patients with more moderate cases of the disease. The clinical trial focused on severe patients has already fully enrolled the number of patients initially intended but has expanded to include thousands of additional patients.

Results on the way

Gilead plans to announce results later this month from the phase 3 study evaluating remdesivir in treating patients with severe cases of COVID-19. Results from the biotech's late-stage study in patients with moderate cases of the disease are expected in late May.

NIAID should also report the results from its study of remdesivir in the latter part of next month. WHO and Inserm probably won't announce data from their respective studies until after June. It's unknown when China will reveal the results from its studies.

For now, Gilead's early results from the use of remdesivir to treat patients with COVID-19 under its compassionate-use program, while encouraging, aren't good enough news to get very excited about. But we won't have to wait very long for more news that could be worth cheering about.

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