Gilead Sciences has reported additional data from the testing of its experimental antiviral drug remdesivir in patients with Covid-19 infection.
The data include findings from a comparative analysis of the Phase III SIMPLE-Severe clinical trial and a real-world retrospective cohort of patients with a severe form of the disease.
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According to the analysis, the drug demonstrated an improvement in clinical recovery and a 62% reduction in the risk of mortality compared to standard of care.
Separate analyses were conducted of subgroups from the Phase III SIMPLE-Severe trial, including a review of the safety and efficacy of remdesivir in various racial and ethnic patient subgroups treated in the US.
Data from these analyses revealed that traditionally marginalised racial or ethnic groups who received the drug had similar clinical outcomes as the overall patient population.
In addition, analyses of Gilead’s compassionate use programme showed recovery by day 28 in 83% of paediatric patients and 92% of pregnant and postpartum women with a broad spectrum of disease severity.
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By GlobalDataThe investigators did not report any new safety signals with remdesivir in these populations.
Gilead also started a global, open-label Phase II/III trial to further assess the safety, tolerability and pharmacokinetics of the drug in paediatric patients from birth to less than 18 years of age.
The company is also working to conduct a study for pregnant women.
Gilead Sciences chief medical officer Merdad Parsey said: “We are working to broaden our understanding of the full utility of remdesivir.
“These data presented at the Virtual COVID-19 Conference shed additional light on the use of remdesivir in specific patient populations, including those that may be susceptible to higher rates of Covid-19 infection, as well as others that are particularly vulnerable, including children and pregnant and postpartum women.”
Earlier this month, Gilead launched a Phase Ia trial of an inhaled version of remdesivir to treat Covid-19 patients in the outpatient setting.
