Five-day remdesivir regimen shows promising clinical benefit in COVID-19 patients, Phase 3 data shows
pharmafile | June 2, 2020 | News story | Manufacturing and Production, Research and Development | COVID-19, Gilead, coronavirus, pharma, remdesivir
Gilead has unveiled eagerly anticipated new Phase 3 data on the addition of its antiviral therapy remdesivir to standard of care (SoC) generated greater clinical benefit than SoC alone in moderately ill COVID-19 patients, specifically those with evidence of pneumonia without reduced oxygen levels.
The new data comes around a month following the release of previous findings from the SIMPLE study which previously compared five-day and 10-day regimens of remdesivir in treating COVID-19.
New findings revealed that clinical improvement was 65% more likely in patients receiving a five-day course of remdesivir plus SoC after 11 days of treatment compared to remdesivir alone
This remdesivir group showed a clinically significant improvement in clinical status at day 11 compared to SoC, with a lower rate of non-statistically significant disease worsening or death.
In those receiving a 10-day regimen of the remdesivir combo, results were observed to be “favourable”, but did not reach statistical significance. Gilead confirmed it would be submitting the results of the study for peer review in the coming weeks.
“We now have three randomised, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. Today’s results showed that when treating moderate disease, a five-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,” commented Dr Merdad Parsey, Chief Medical Officer at Gilead.
“The National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes,” he continued. “Our SIMPLE-Severe study showed that when treating patients with severe disease, five days of remdesivir led to similar clinical improvements as a 10-day course. 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, paediatric studies and the development of alternate formulations.”
Remdesivir is currently approved in Japan as a COVID-19 treatment, but elsewhere it is only being used in an emergency capacity, such as in the US where it has secured Emergency Use Authorization from the FDA.
Matt Fellows
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