Remdesivir clinical trial results : Gilead Sciences said that the phase 3 SIMPLE trial, which has been evaluating the Covid-19 drug candidate remdesivir for the treatment of hospitalized patients with moderate pneumonia associated with novel coronavirus, has yielded promising results.
According to the US biopharma company, the Covid-19 drug candidate delivered significantly greater clinical improvement for its five-day treatment course compared to treatment with just standard of care. For the 10-day treatment course with the antiviral candidate, although the results were favorable, they were not statistically significant compared to standard of care alone.
In the five-day remdesivir treatment group, 65% of them were more probable to have clinical improvement at Day 11, in comparison to those in the standard of care patient group.
Gilead Sciences stated that there weren’t any new safety signals noted with the Covid-19 drug candidate across the two treatment arms.
Approved already in Japan for the treatment of SARS-CoV-2-infected patients, remdesivir was granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for novel coronavirus treatment.
Commenting on remdesivir clinical trial results, Merdad Parsey – chief medical officer of Gilead Sciences said: “Our SIMPLE-Severe study showed that when treating patients with severe disease, 5 days of remdesivir led to similar clinical improvements as a 10-day course.
“The additional data we have in hand today will further guide our research efforts, including evaluating treatment earlier in the course of disease, combination studies with other therapies for the most critically ill patients, pediatric studies and the development of alternate formulations.”