- The World Health Organisation accidentally posted a summary of study results finding that a leading experimental coronavirus treatment did not help a group of patients with severe cases, according to reports from the Financial Times and STAT News.
- A WHO representative confirmed the mistake, saying that the summary was quickly removed from its website.
- The results came from a study of patients in China. After a month, about 14% of the patients taking the antiviral drug remdesivir had died, compared with about 13% of those who got a placebo, STAT reported.
- Gilead said that the summary posted on WHO’s site “included inappropriate characterizations of the study” and that the data “suggest a potential benefit for remdesivir, particularly among patients treated early in disease.”
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A leading coronavirus treatment candidate did not help patients with severe coronavirus cases in a trial survive better than a placebo group, according to a summary of preliminary study results reported by STAT News and the Financial Times.
The World Health Organisation accidentally posted a summary of the study results on its website on Thursday, a representative confirmed. That post was removed, but not before several news outlets noticed it. Gilead’s stock fell more than 6% on Thursday afternoon.
The summary was of a clinical trial of patients with severe COVID-19 cases in China. Participants were randomly assigned to receive an IV infusion of either remdesivir, an experimental antiviral drug, or a placebo.
The summary said that about 14% of those taking remdesivir had died after a month, compared with about 13% of those in the placebo group, according to STAT. It said it did not find a meaningful difference in how fast patients improved between the two groups.
‘Pretty close to a worst case scenario’
“This is pretty close to a worst case scenario as not only did the clinical effect not manifest, but there wasn’t even an antiviral effect to explore,” the Baird biotech analyst Brian Skorney told investors in a note.
It was the second unusual leak of remdesivir study results in days. STAT reported last week on a leaked video showing University of Chicago researchers discussing promising results from a different remdesivir study.
In a statement, Gilead said the results accidentally posted by WHO were “inconclusive” because researchers ended the trial early without enrolling as many patients as they intended. They said there was a lack of eligible participants as new coronavirus cases have recently fallen in China.
The trial ended up including 237 participants, with 158 receiving remdesivir and 79 receiving a placebo. It was designed to enroll 453 people.
“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,” Gilead said.
Umer Raffat, an Evercore ISI biotech analyst, said that between the two recent leaks, he thinks the truth “is somewhere in the middle.”
Gilead’s trial requires patients to start taking the drug within three days of a positive COVID-19 test. The China study allowed patients to enroll up to 12 days after they developed symptoms.
“This point on exact timing of starting remdesivir is key,” Raffat told investors, echoing Gilead’s statement about the potential to help patients earlier on in the disease.
More studies on remdesivir are coming
“There are multiple ongoing Phase 3 studies that are designed to provide the additional data needed to determine the potential for remdesivir as a treatment for COVID-19,” Gilead said. “These studies will help inform whom to treat, when to treat and how long to treat with remdesivir.”
There is still no quality data showing that remdesivir works or doesn’t work on COVID-19. The antiviral was previously tested in Ebola patients and performed worse than other treatment candidates.
Skorney said results from a remdesivir trial run by the US’s National Institutes of Health would be “crucial.” That study is randomizing patients between remdesivir and a placebo and is expected to produce results by late May.
Here’s Gilead’s full statement:
We regret that the WHO prematurely posted information regarding the study, which has since been removed. The investigators in this study did not provide permission for publication of results.
Furthermore, we believe the post included inappropriate characterizations of the study. Importantly, 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. We understand the available data have been submitted for peer-reviewed publication, which will provide more detailed information from this study in the near future.
There are multiple ongoing Phase 3 studies that are designed to provide the additional data needed to determine the potential for remdesivir as a treatment for COVID-19. These studies will help inform whom to treat, when to treat and how long to treat with remdesivir. The studies are either fully enrolled for the primary analysis or on track to fully enroll in the near future.
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