According to a draft document published in error by the World Health Organization (WHO), Gilead Sciences' remdesivir failed to improve the condition of patients with severe COVID-19 participating in a Chinese clinical trial, nor was the drug found to reduce the virus' presence in the blood. The WHO stated that the document, which is undergoing peer review, was "inadvertently posted on [our] website and taken down as soon as the mistake was noticed," adding they are waiting for a final version from the authors before commenting.
The news comes days after a report said early results from another study conducted at the University of Chicago found that COVID-19 patients, most with severe disease, who were given remdesivir "[saw] rapid recoveries in fever and respiratory symptoms." Still, a spokesperson for the university urged caution on the results, noting that they were only "partial data from an ongoing clinical trial," although the report had sent Gilead shares up as much as 16% on April 17, a day after it was published.
In the Chinese trial, researchers studied 237 patients, giving the drug to 158 and comparing their progress with the remaining 79. Aside from appearing to show a lack of efficacy, remdesivir was also linked to significant side effects in some patients, with 18 of them having to be taken off the therapy. The study was one of several remdesivir trials in China that were recently terminated, with authorities there saying they are no longer able to recruit enough patients to fully enrol studies.
Gilead, whose shares tumbled as much as 8.5% on the latest news, issued a statement saying the draft document mistakenly released by the WHO contained "inappropriate characterisations" about the study. Chief medical officer Merdad Parsey noted that "because this study was terminated early due to low enrollment, it was underpowered to enable statistically meaningful conclusions…As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease." He said Gilead plans to share results at the end of this month from its study of remdesivir in patients with severe COVID-19, while data from another study in patients with moderate disease are expected at the end of May.
Baird analyst Brian Skorney said the latest leaked results "should be very sobering" given the lack of effect on clinical improvement or mortality, and he suggested the outcome is "pretty close to a worst-case scenario." However, Piper Sandler's Tyler Van Buren pointed out that "no one expected remdesivir to work in all patients, and antivirals are best when used early," adding "the bottom line is that stating the trial 'flopped' appears overly aggressive and premature, particularly in light of Gilead's comments."
Analyst Michael Yee of Jefferies noted that the Chinese study "was stopped due to low enrollment and never completed." He said the readout next month from Gilead's study of remdesivir in patients with moderate COVID-19 disease "against a placebo, may show some modest benefit, but it's not a magic cure pill." Meanwhile, SunTrust analyst Robyn Karnauskas reiterated "we don't see Gilead making a profit from this drug. We do not include remdesivir in our model."
Earlier this month, study findings published in the NEJM showed early positive results for remdesivir, with 68% of hospitalised patients with COVID-19 improving on the drug. The study looked at patients who had been treated with remdesivir on a compassionate-use basis. Analysts who later commented on the work, cautioned that while the data looked promising, it was difficult to draw any firm conclusions about the efficacy of Gilead's drug (for related analysis, see ViewPoints: Any data is good data for remdesivir).
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