Gilead Sciences, Inc. (GILD) shares were down 3.43% on Tuesday after Gilead reported mixed results from a clinical trial investigating remdesivir’s effectiveness against COVID-19.
The trial found that COVID-19 patients given remdesivir for five days were statistically more likely to see medical improvement at day 11 than patients given standard care alone. However, the trial found that no improvement of statistical significance was seen in patients given remdesivir for ten days.
The trial compared five day and ten day remdesivir regiments plus standard care with standard care alone. Hospitalized patients with moderate COVID-19-related pneumonia were randomized 1:1:1 to be given remdesivir for five days, ten days or standard care only. Clinical status at day 11 was the primary endpoint. The secondary objective of the trial was to determine remdesivir’s rate of adverse events.
The medication was generally well-tolerated in patients receiving the five and ten day regimens. No new safety signals were found in either the five or ten day groups. The most common side effects seen in the trial were diarrhea, nausea and headaches.
Gilead plans to release the full data for publication in a peer-reviewed journal soon.
Remdesivir was originally studied by Gilead as a potential Ebola treatment. Lab experiments hinted that it might work against COVID-19.
Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the improvements seen in patients taking remdesivir were not dramatic.
“The data show that there is only a small difference between the groups in improvement,” he said.
“These improvements are not dramatic – they are not a ‘game changer’ in the terrible jargon, but at least there is some genuine evidence of improvement. For the patients it is good news that few died, but the evidence therefore that remdesivir improves mortality in these patients is uncertain and limited,” he added.
“Remdesivir is one of the only drugs to show some promise, but the benefits are not large and we need to have more transparent data before we can form a good judgment.”
“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,” said Merdad Parsey, MD, chief medical officer of Gilead.