Gilead Sciences has reported positive final results from the Phase III ACTT-1 clinical trial of its investigational drug, Veklury (remdesivir), for the treatment of adults hospitalised with Covid-19.
The data from the study, conducted by the National Institute of Allergy and Infectious Diseases (NIAID), showed that Veklury-treated patients had a faster time to recovery than previously reported.
Published in the New England Journal of Medicine (NEJM), the latest data is backed by preliminary results published in the journal in May 2020.
According to the final results, Veklury demonstrated consistent, clinically meaningful improvements on various outcome measures versus placebo.
The randomised, placebo-controlled ACTT-1 trial analysed a ten-day course of Veklury plus standard of care (SOC) in over 1,000 hospitalised adults with mild/moderate to severe Covid-19 symptoms.
In the preliminary day 15 results, Veklury plus SOC reduced the time to recovery by four days as compared to placebo plus SOC.
Veklury plus SOC was superior in shortening the time to recovery to day 29 versus placebo plus SOC, meeting the primary endpoint.
In the final day 29 results, Veklury-treated patients experienced clinical recovery five days faster than those on placebo, with a median time to recovery of ten and 15 days, respectively.
An increased recovery rate of 29% was also observed with Velkury compared to placebo.
The trial also met key secondary study endpoint of clinical status at day 15. A higher benefit with the drug was observed when administered within ten days of symptom onset.
Overall study population showed a trend toward decreased mortality, a secondary study endpoint, at days 15 and 29 in the study drug arm versus placebo. In a post-hoc analysis, Veklury lowered mortality by 70% at day 29 in patients on low-flow oxygen at baseline.
Other secondary endpoints, such as time to discharge, oxygen use, and incidence and duration of new oxygen use or other respiratory support were also achieved.
Gilead Sciences chief medical officer Merdad Parsey said: “The robust evidence on the clinical benefits of Veklury, coupled with significantly expanded global supply, puts an important treatment option in the hands of healthcare providers around the world.”
Veklury is undergoing multiple Phase III Covid-19 trials involving various patient populations, formulations and combination therapies.