Early compassionate use data on a drug that Gilead Sciences is developing for Covid-19 show that nearly 70% of patients receiving it showed clinical improvement, the company said Friday.
The Foster City, California-based biotech company announced the publication of data on 53 hospitalized patients in the U.S., Canada, Japan and Europe with severe complications of Covid-19 who received the drug remdesivir on an individual compassionate use basis, in The New England Journal of Medicine.
The company repeatedly cautioned that the data are limited and cannot be the basis from which to draw definitive conclusions about remdesivir’s efficacy, noting issues inherent in interpretation of compassionate use data like small sample sizes, relatively short follow-ups, lack of a control group and potentially missing data. To that end, Gilead is running two Phase III clinical trials of the drug, in patients with severe and also moderate disease.
Shares of Gilead were down about 2% on the Nasdaq when markets closed.
“We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said the article’s lead author, Cedars-Sinai Medical Center Director of Hospital Epidemiology Dr. Jonathan Grein, in a statement on behalf of the company. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
The data showed that 68% of patients overall saw an improvement in terms of the oxygen support they required over a median follow-up period of 18 days after receiving the first dose of the drug. Of the patients who had been on mechanical ventilation, 57% were extubated, while nearly half of the patients overall were discharged from the hospital. The cumulative incidence of clinical improvement after 28 days of follow-up was 84%. However, the data showed that clinical improvement occurred less frequently among patients who were on invasive ventilation – meaning they used ventilation equipment that penetrated the mouth, nose or skin to form an artificial airway – compared with non-invasive ventilation, as well as those who were 70 or older. Meanwhile, seven patients died, translating into a mortality rate of 13%, with most of them being those who were on invasive ventilation. Other factors associated with greater risk of dying were the aforementioned old age and reduced kidney function.
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