Gilead Sciences has announced positive results from the phase 3 trial of investigational antiviral remdesivir in patients with severe COVID-19.
The open-label and phase 3 SIMPLE trial has assessed five-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalised patients with severe manifestations of COVID-19 disease.
According to the company, the trial showed that patients securing a10-day treatment course of remdesivir achieved similar improvement in clinical status compared against those taking a five-day treatment course.
The initial phase of first SIMPLE trial randomised 397 patients in a 1:1 ratio to receive remdesivir 200mg on the first day, followed by remdesivir 100mg each day until day 5 or 10, administered intravenously, in addition to standard of care.
Gilead has not yet secured approval anywhere across the globe, as well as not yet showed to be safe or effective for the treatment of COVID-19.
The trial aims to determine whether a shorter, five-day course of remdesivir may achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir.
Secondary objectives of the trial comprised of rates of adverse events and additional measures of clinical response in both treatment groups.
The time to clinical improvement for 50% of patients was 10 days in the five-day treatment group and 11 days in the 10-day treatment group in the trial.
The patients in the study who secured remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms in an exploratory analysis.
Gilead started two randomised, open-label, multi-centre Phase 3 SIMPLE clinical trials for remdesivir in countries with high prevalence of COVID-19 infection.
Gilead Sciences chief medical officer Dr Merdad Parsey said: “Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic.
“Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilise the drug.
“These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir.”
In March this year, Gilead Sciences signed an agreement to acquire clinical-stage immuno-oncology company Forty Seven for $4.9bn.