Leaked Study Data Suggests Gilead’s Remdesivir Did Not Benefit COVID-19 Patients

Clinical data

Shares of Gilead Sciences fell after reports suggest remdesivir failed to distinguish itself as a treatment for COVID-19 in a clinical study conducted in China. But, there are some questions about the veracity of the study.

Results of the study were apparently not meant to be made public at the time and were inadvertently posted to the World Health Organization’s website before being removed. That brief posting though was enough to sour investors as the company’s stock has fallen nearly 5% to $76.60 per share as of 1:08 p.m. The data from the study suggests that Gilead’s antiviral drug showed no benefit as a treatment for COVID-19 patients. WHO spokesperson Tarik Jasarevic said the data from the Chinese study has not undergone peer review and the organization is awaiting a final version from WHO, STAT reported.

According to a report in the Financial Times, the data from the study showed remdesivir did not improve patients’ condition or reduce the pathogen’s presence in the bloodstream. There were also concerns about some potential side effects caused by the drug. The study suggests more patients died on remdesivir than those on placebo, 13.9% compared to 12.8%, respectively. The difference was not considered statistically significant, according to STAT.

Despite the negative report from the China study, Gilead Sciences said the data from that study suggests a potential benefit for remdesivir against COVID-19. Spokesperson Amy Flood told STAT that the post on the WHO website included an “inappropriate characterization of the study.” The data was posted from the same Chinese study that was halted early because it did not have enough patients enrolled. Therefore, Flood said statistically meaningful conclusions cannot be drawn at this time. Flood added that “trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease,” according to STAT’s report.

Remdesivir is an antiviral drug that has been studied as a potential treatment for Ebola, Marburg, MERS and SARS. MERS and SARS are both caused by coronaviruses that have at least some similarities to the coronavirus causing COVID-19.

Earlier this month, Gilead announced it suspended a Phase III trial for mild to moderate patients had been ended because of a lack of patients to enroll. While this trial was halted, Gilead is conducting other clinical studies of remdesivir in COVID-19 cases. Gilead recently published data in the New England Journal of Medicine on 53 patients who received the drug under a compassionate use basis that suggested promising results. According to that study, 68% of remdesivir patients improved. Promising results have also been seen from a study conducted at the University of Chicago. Although the company cautioned against reading too much into that data, the study showed patients treated with remdesivir recovered more quickly and were discharged from the hospital in one week.

Gilead anticipates results from some of its clinical trials within the coming weeks. As BioSpace previously reported, data from the University of Chicago trial and other trials are expected later this month. Results from clinical trials on patients with moderate disease symptoms is expected in May. There are also two additional trials assessing remdesivir being conducted by the National Institutes of Health, which have a more robust trial design—an adaptive, randomized, double-blind, placebo-controlled study.

Source

About the Author: Biotech Today

You might like