In the 5-day remdesivir group, patients were 65% more likely to see clinical improvement at 11 days compared to those treated with standard-of-care only.
One month after Remdesivir was granted Emergency Use Authorization for use in COVID-19 patients, Gilead Sciences reported results from a Phase III study that showed the drug helped some moderately-ill patients.
The company announced this morning that following an evaluation of 5-day and 10-day courses of treatment with the antiviral drug plus standard-of-care, Phase III results showed positive outcomes against standard-of-care alone. In the 5-day remdesivir group, patients were 65% more likely to see clinical improvement at 11 days compared to those treated with standard-of-care only. At Day 11, a higher proportion of patients in the 5-day treatment group achieved improvement in clinical status versus the standard of care group, achieving statistical significance. In addition, non-statistically significant increases in clinical worsening or death were observed in the standard of care only group compared with the remdesivir groups, Gilead said.
The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance, Gilead Sciences said.
Gilead Sciences Chief Medical Officer Merdad Parsey said there have now been three randomized clinical trials with remdesivir in COVID-19 and the studies have shown that the company’s antiviral drug improved clinical outcomes by several different measures.
“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,” Parsey said in a statement.
Parsey noted that the study, conducted by the National Institute of Allergy and Infectious Diseases, showed remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes.
“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,” Parsey added.
No new safety signals were observed and Gilead intends to submit full data from the Phase III SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia for publication in a peer-reviewed journal in the coming weeks.
Francisco Marty, an infectious disease physician at Brigham and Women’s Hospital and trial investigator, said the latest remdesivir results in COVID-19 demonstrate that if patients can begin a 5-day treatment course during the early days of the diseases, clinical outcomes can be significantly improved.
Company shares were down about 4% this morning following the release as some investors were hoping to see more significant results regarding efficacy.
“Since the earliest days of the outbreak, Gilead has been focused on rapidly studying the potential for our investigational antiviral remdesivir to treat patients with COVID-19. We set out to answer important questions about if, how and when to use remdesivir, conducting multiple studies in parallel and on a significantly compressed timeline, given the urgency of the public health need. Building on a foundation of knowledge from our earlier studies of remdesivir in other viruses, we have conducted one of the fastest ever late-stage development programs to bring forward a potential treatment for COVID-19,” Parsey said.
At the end of April, the U.S. Food and Drug Administration granted EUA to remdesivir following trial results that showed COVID-19 patients receiving remdesivir had a 31% faster time to recovery than the placebo group. Patients who received remdesivir recovered about four days faster than those on placebo, a median of 11 days versus 15 days, respectively.
