Gilead plummets latest data leakage from China vaccine trials

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The actions of Gilead Sciences Inc. were whipped for the second time in a week after a summary of a Chinese trial of its drug COVID-19 appeared to show that it was a failure.

The synopsis, which the company and a scientist working on the trial said did not accurately represent actual results, dropped Gilead’s shares to 8.5% on Thursday. The broader market also appeared to be falling, with the S&P 500 briefly giving up all of its gains for the day before rebounding.

Gilead’s drug, remdesivir, is one of the most monitored therapies among dozens developed and tested as a potential treatment for COVID-19 patients. The World Health Organization, which helped coordinate the global response to the virus, said it accidentally published the results on a website that tracks therapies for the disease.

The resume was quickly deleted, but the job details were reported by the Financial Times and published by Stat. They showed that the drug was not associated with faster improvement in patients; and 13.9% of the patients who received the drug died, compared to 12.8% who received standard care.

Gilead’s shares have been sent in incremental drug reports as investors grasp any evidence that the company’s compound may be an effective therapy for COVID-19 patients. Stocks jumped 9.7% on April 17 after a report said the drug appeared to have helped a group of Chicago patients who were part of a separate trial.

Gilead Response

The pharmaceutical company and a scientist involved in the trial, however, challenged characterizing the result as outright failure.

“This is not correct,” said Frederick Hayden, an infectious disease expert at the University of Virginia medical school, when asked if the results showed that the remdesivir had failed. Hayden helped the Chinese doctors conduct the study. “My interpretation of them is not consistent with this title. “

Gilead, in a statement, said the summary distorted the results of the study, which was stopped soon after there weren’t enough patients. A study with a low enrollment rate may lead to less conclusive results. Hayden said that there was an error in the original manuscript and that it had since been revised.

He said the study was under review in a newspaper, which he did not identify. He declined to comment until the study was published.

Gilead, in his statement, said that “the trends in the data suggest a potential benefit for remdesivir, especially in patients treated early”. The company said the complete data is submitted for review and publication.

Severe patients

The study was one of two main trials in China on remdesivir and involved patients with severe COVID-19 cases. This group was considered one of the most difficult to treat with antiviral drugs, because by the time the disease progresses, there may already be significant lung damage. In addition, the immune system can get out of control in some patients with advanced disease, a process that antivirals like the drug Gilead will not help.

“It is disappointing not to at least show positive trends in efficiency or safety, so expectations will drop now for studies sponsored by Gilead,” said Michal Yee, analyst at Jefferies Financial Group Inc. in New York. “However, this may not be shocking in severe patients who are too far away. “

The results of the company’s study in severe patients are expected next week, said Yee. The absence of a comparison group in the trial can make its assessment difficult. Another moderate patient study, which includes a control group, is scheduled for late May.

Gilead has previously stated that healthier patients and those who were treated early, before being completely overwhelmed with the infection, could do better, Yee said.

“The moderate May study against a placebo may show modest benefit, but it is not a magic pill,” he said.

Not enough patients

The China-led study was chaired by Bin Cao, a Beijing pulmonologist who traveled to Wuhan when the pandemic started to set in and started the trial on February 6. At the time, the number of cases in the city was increasing rapidly and doctors were looking for potential therapies to help their patients survive.

But with aggressive blockages in place in the region, the study – originally designed to enroll 450 patients – could not find enough patients. It was halted on March 30 after signing just over half of its target.

Insufficient enrollment in a trial may make an inconclusive result more likely, unless the drug is overwhelmingly beneficial or massively harmful.

Remdesivir, an infused antiviral drug, was developed in part to fight Ebola and has shown promise in laboratory tests against SARS and MERS, two previous coronaviruses that have triggered epidemics.

Tarik Jasarevic, a WHO spokesperson, said the study is under peer review and the health agency is awaiting a final version before making comments.



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