A report from STAT suggests the drug made by Gilead Sciences is showing big promise in treating "severe" coronavirus patients in Chicago. "We've only had two patients perish", said Kathleen Mullane, the University of Chicago infectious disease specialist in charge of the remdesivir studies for the hospital.
Gilead on Thursday said the totality of the data from the trial needed to be analyzed, and expects to report results from the study in severe COVID-19 patients at the end of the month, and data from other trials in May.
Gilead Sciences initially developed Remdesivir to treat Ebola patients in West Africa in 2014 and was also tested as a treatment for SARS and hepatitis C. In February, the company announced its plan to test the safety and efficacy of Remdesivir in COVID-19 patients and has launched numerous studies since.
The University of Chicago results follow other encouraging findings from a study published April 10 in the New England Journal of Medicine that followed 53 patients who were treated with remdesivir in the U.S., Europe, Canada and Japan on a compassionate use basis. Of them, 113 had severe disease.
The drug manufacturer's severe COVID-19 study includes 2,400 participants from 152 different clinical trial sites worldwide.
Mullane cautioned that the encouraging results can't yet be used to draw too many conclusions, as the clinical trials don't include a placebo group for comparison.
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"Information from an internal forum for research colleagues concerning work in progress was released without authorization", the university said, according to the Financial Times (FT). "Drawing any conclusions at this point is premature and scientifically unsound", the university added. Twelve hours later the treatment group received a dose of remdesivir intravenously, and then received a daily intravenous booster dose thereafter for the next six days.
What's next? Remdesivir has the potential to become the first approved treatment for the coronavirus if it continues to produce safe and effective results.
"What we can say at this stage is that we look forward to data from ongoing studies becoming available", Gilead said in a statement to STAT. These drugs interfere with the viral polymerase enzyme (which in the case of HIV is known as reverse transcriptase), acting as defective building blocks that prevent a virus from copying its genetic material.
We've talked about it before, as remdesivir is an anti-viral that's included in the World Health Organization's (WHO) massive COVID-19 trial. The drug was the first identified as having the potential to impact the new coronavirus, according to the report. Since Covid-19 data readouts have implications for the entire economy as a whole, the report was likely a factor in Friday's market rally. "Some of these answers will start to emerge in the coming weeks as we receive the first data from the various clinical trials underway".
"While the article paints a pretty picture, we think the ensuing exuberance shows a lack of critical analysis", said Baird analyst Brian Skorney.