Gilead Sciences said that a phase 3 trial with its investigational antiviral remdesivir has delivered positive results in hospitalised patients with moderate Covid-19 pneumonia.
Remdesivir has been found to have provided significantly greater clinical improvement following its five-day treatment course, in comparison to treatment with standard of care alone, in the SIMPLE trial.
The open-label study also assessed a 10-day course of the investigational antiviral plus standard of care in comparison to standard of care alone.
For patients in the five-day remdesivir treatment arm, 65% of them were more likely to have clinical improvement at Day 11 compared with those in the standard of care arm.
According to Gilead Sciences, the odds of improvement in clinical status with the 10-day treatment course of the investigational antiviral compared to standard of care were also favorable but could not reach statistical significance.
Brigham and Women’s Hospital infectious diseases physician Francisco Marty said: “Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve.
“These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients.”
The company said that no new safety signals were observed with remdesivir across the treatment groups. Currently, the antiviral candidate has approval in Japan as a treatment for patients infected with SARS-CoV-2, the virus that results in Covid-19.
Gilead Sciences chief medical officer Merdad Parsey said: “Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results.
“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.”
In early May, the investigational antiviral was granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for the treatment of Covid-19. The EUA is said to have facilitated wider use of remdesivir for the treatment of hospitalised patients with severe Covid-19 disease, enabling access to the drug candidate at more hospitals across the US.