A drug developed to treat the virus that causes Covid-19 was able to reduce the amount of time patients with moderate disease took to recover compared with standard-of-care treatments, though an analyst called the treatment effect “modest.”
Foster City, California-based Gilead Sciences announced Monday the release of top-line results from the Phase III SIMPLE study of remdesivir in patients with moderate Covid-19 pneumonia. The drug does not have Food and Drug Administration approval, but does have an emergency use authorization from the agency for patients hospitalized with severe disease caused by the SARS-CoV-2 virus.
Shares of Gilead were down 4% on the Nasdaq following the news.
Data from the study showed that of 191 patients who received the drug via intravenous infusion for five days, 70% and 76% saw at least a two- or one-point increase on a scale of clinical improvement, respectively, while 65% and 70% of the 193 patients in the 10-day group saw a similar improvement. Among the 200 patients in the standard-of-care group, the respective figures were 61% and 66%. However, the figures for the 10-day treatment group did not reach statistical significance. Meanwhile, patients in the standard treatment group were somewhat more likely to require oxygen support, experience at least a one-point worsening of symptoms or to die, though the improvement in death rates on the drug likewise was not statistically significant.
The study is the second randomized, controlled trial of remdesivir to produce results in the last couple of months, after the Phase III trial of the drug sponsored by the National Institute of Allergy and Infectious Diseases, which led to the FDA issuing an EUA. That study also showed a statistically significant improvement in the amount of time in which patients taking remdesivir recovered from Covid-19, along with a non-statistically significant improvement in the rate of death. Data from the NIAID study were published in The New England Journal of Medicine last week.
In a note to investors, Baird analyst Brian Skorney wrote that the study’s data reinforced the view that the drug’s impact was limited. However, another analyst, Cowen’s Yaron Werber, called the five-day data “encouraging.”
“This morning’s top-line results from the SIMPLE trial of remdesivir in moderate COVID-19 patients continue to indicate a very marginal clinical benefit, while reinforcing that a benefit is likely more than random noise,” Skorney wrote. “We continue to believe that both the commercial opportunity for Gilead and the macro benefit of remdesivir to society, at large, is very limited.”
Photo: Ulrich Perrey, Pool/AFP, Getty Images
