Shares in Gilead Sciences jumped as much as 16% on Friday after a report suggested that patients with COVID-19 who were treated with remdesivir were "seeing rapid recoveries in fever and respiratory symptoms." The early data, which were reported in STAT, come from patients treated at the University of Chicago Medicine as part of Gilead's two Phase III studies of the experimental antiviral.
According to STAT, the University of Chicago Medicine recruited 125 patients with COVID-19 into the trials, with 113 of these subjects having severe disease. "The best news is that most of our patients have already been discharged, which is great. We've only had two patients perish," remarked Kathleen Mullane, who is overseeing the studies at the University of Chicago Medicine.
Mullane suggested that data for the first 400 patients in the study would be "locked" by Gilead on April 16, indicating that results would shortly follow. In a video reportedly seen by STAT, Mullane said "when we start [the] drug, we see fever curves falling," adding "we have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well."
However, Mullane also offered caution, partly because the study of patients with severe disease, which includes 2400 participants, does not include a placebo group for comparison. "Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three," she said.
A spokesperson for the University of Chicago also urged caution on the results, noting that "partial data from an ongoing clinical trial is by definition incomplete and should never be used to draw conclusions about the safety or efficacy of a potential treatment that is under investigation." Meanwhile, in response to the news, Gilead said "anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19."
Commenting on the study in patients with severe disease, Evercore ISI analyst Umer Raffat noted that it specifically excluded those who are on mechanical ventilation. The trial is investigating five- and 10-day treatment courses of remdesivir and has a primary endpoint of a comparison of patient improvement between the two treatment arms, as measured using a seven-point numerical scale that encompasses death and discharge from hospital, with various degrees of supplemental oxygen and intubation in between.
Other recent findings also support the potential of remdesivir, with results from a cohort analysis demonstrating that the drug improved clinical outcomes in 68% of 53 hospitalised patients with severe complications from COVID-19. However, analysts have been quick to weigh in on the data, cautioning about drawing any firm conclusions (for a deeper look, read ViewPoints: Any data is good data for remdesivir).
Meanwhile, earlier this week, researchers in China were forced to scrap a Phase III study of remdesivir in patients with mild-to-moderate COVID-19, saying "the epidemic…has been controlled well at present, no eligible patients can be recruited." The move came days after a clinical trial of remdesivir targeting severely ill COVID-19 patients in China was halted two months into the study due to "stalled enrollment."
For related analysis, listen to our latest podcast from FirstWord executive editors Simon King and Michael Flanagan, including a discussion of further potential treatment options and the politicisation of different approaches in the absence of meaningful data from controlled clinical studies.
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