While Gilead Sciences’ Phase III studies of the drug remdesivir are busy recruiting patients with Covid-19, two Phase III trials of the drug in China have been stopped because no patients could be recruited thanks to the outbreak being brought under control there.
On Wednesday, the pages for the studies – one in patients with mild to moderate Covid-19 and another in patients with severe disease, both sponsored by Capital Medical University in Beijing – were updated to say that the former had been suspended, and the latter terminated. In both cases, the stated reason was that “The epidemic of COVID-19 has been controlled well at present,” and thus no eligible patients could be recruited or enrolled.
Shares of Foster City, California-based Gilead were down more than 3% Wednesday afternoon. The Dow Jones overall had fallen nearly 2% due to low retail sales.
The mild-to-moderate disease study had been designed to enroll 308 patients, while the severe disease study had been designed to enroll 452, but ultimately enrolled 237, according to ClinicalTrials.gov. It is unclear how many patients were enrolled in the mild-to-moderate study.
Gilead spokesperson Chris Ridley noted in an email that the studies sponsored by the company – one in moderate disease and one in severe disease – were ongoing, but declined to comment on when the Chinese studies would have data available given that Gilead was not sponsoring them.
In a note to investors Friday morning, RBC Capital Markets analyst Brian Abrahams wrote that because no data have been revealed from the severe study in Beijing, which unlike Gilead’s studies has a placebo control, despite the “reasonably robust” number of patients it enrolled, it suggests that any benefits observed were likely inconclusive. Consequently, he wrote, the likelihood of remdesivir demonstrating substantial activity “remains at best 50/50.” Data from the Gilead studies, as well as a study sponsored by the National Institute of Allergy and Infectious Diseases, is expected this month and next month.
Gilead last week adjusted the protocols of its two studies to increase the number of patients while also changing the primary endpoints to one encompassing a seven-point outcomes scale, ranging from discharge from the hospital to death. There are anecdotal reports that the moderate-disease study has been slow to recruit patients, because of difficulty capturing those patients at the hospital and because many are opting for hydroxychloroquine and chloroquine thanks to publicity around those drugs.
Very limited data on 53 patients with severe Covid-19 who received remdesivir through compassionate use protocols were announced last Friday. The data were suggestive of a benefit, but the company cautioned they were not definitive.
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