Covid-19: Gilead’s Antiviral Drug Remdesivir Said To Have Flopped In First Clinical Trial But Company Disputes Results

Gilead Sciences Inc.’s experimental antiviral drug remdesivir failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a clinical trial conducted in China, Financial Times reported.

The drugmaker disputed the conclusion saying that findings were inconclusive as the study was prematurely terminated.

According to the FT report, a summary of the study results was inadvertently posted to the website of the World Health Organization but accessed by FT before it was taken down.

According to the draft documents that were later taken down from WHO site, the clinical trial in China enrolled 237 patients with 158 receiving remdesivir (administered by intravenous infusion) compared with 79 who got a placebo. The rate of death was similar at 13.9% for remdesivir versus 12.8% in the control group. The drug also did not improve patients’ condition or reduce the pathogen’s presence in the bloodstream.

Gilead in a statement said the WHO posting included inappropriate characterizations of the study, which was terminated early due to low enrollment and, as a result, cannot be used to make statistically meaningful conclusions.

“The study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease,” the company said without providing details to back up that assertion.

The company’s shares plunged by 4.3% after the inadvertent release of the findings.

Last Thursday, shares of Gilead Sciences Inc jumped 12.7% in after-hours trading after publication of a report that suggested that Covid-19 patients, who are getting the company’s experimental drug remdesivir, staged quick recovery, with most going home in days

The patients who took part in a clinical trial of the drug have all had severe respiratory symptoms and fever, but were able to leave the hospital after less than a week of treatment, a doctor leading the trial was quoted as saying.

"The best news is that most of our patients have already been discharged, which is great. We've only had two patients perish," Dr. Kathleen Mullane, an infectious disease specialist at the University of Chicago who is leading the clinical trial, said in the video.

In the first week of April, Gilead Sciences had announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with its experimental antiviral remdesivir administered under a compassionate trial program.

The study, published in the New England Journal of Medicine, involved 53 severely ill patients across US, Canada and Europe who were given remdesivir as part of a “compassionate use” program.

Gilead is conducting tests of the drug in 2,400 patients with severe Covid-19 symptoms in 152 trial sites around the world. It's also testing the drug in 1,600 patients with moderate symptoms at 169 hospitals and clinics around the world.

Remdesivir, a drug originally made by Gilead Sciences, was tested against Ebola with little success, but multiple studies in animals showed the drug could both prevent and treat coronaviruses related to Covid-19, including SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome).