New Delhi: Dampening expectations, remdesivir — touted as a possible medication against Covid-19 — has failed to cure critical patients suffering from the novel coronavirus infection in China, according to reports.
The closely watched experimental antiviral medicine, which was earlier tested for treatment of Ebola, is manufactured by American drug maker Gilead Sciences.
According to media reports, Remdesivir has failed in its first randomised clinical trial in China. These reports were based on the inadvertent release of the results of clinical trials by the World Health Organization (WHO) Thursday.
A screenshot of the WHO posting, captured by the medical news website STAT before it was removed, said the trial enrolled 237 patients. It said 158 patients were receiving Remdesivir compared with 79 who got a placebo. The death rate was 13.9 per cent for Remdesivir, similar to the 12.8 per cent in the control group.
“In a ‘gold standard’ trial of 237 patients, some of whom received remdesivir while others did not, the drug did not work. The trial was also stopped early because of side-effects,” said the media report by The Guardian quoting the STAT news screenshot.
A draft summary of the report was uploaded on the website of WHO which, in turn, was first reported by the Financial Times and Stat News. The summary was later removed by WHO.
“A draft manuscript was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is now undergoing peer review and we are waiting for a final version before WHO comments on it,” WHO spokesperson Daniela Bagozzi told The Guardian.
The results are contrary to the earlier encouraging ones that stated the drug helped in the rapid recovery of Covid-19 patients by reducing fever and improving respiratory symptoms.
‘Too soon to conclude’
Drug maker Gilead said the findings were inconclusive because the study was terminated early.
In a statement, Gilead said: “Today, information from the first clinical study evaluating the investigational antiviral remdesivir in patients with severe COVID-19 disease in China was prematurely posted on the World Health Organization website … This information has since been removed, as the study investigators did not provide permission for the publication of the results.
“We believe the post included inappropriate characterizations of the study. The study was terminated early due to low enrollment and, as a result, 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,” the statement said.
Indian companies eye remdesivir
Indian drug makers have been preparing generic copies of remdesivir.
Key pharma companies including Cipla, Glenmark and Dr. Reddy’s, according to industry sources, have started working on the development of the drug which is under patent protection until 2035.
The companies are hoping that Gilead Sciences, which owns the drug patent, will grant them licensing provisions, like it did with hepatitis C drug Sovaldi in 2014, so production can begin.
But for now, companies are allowed to formulate the drug, strictly for research and development purposes under the Bolar Provision of Patent Law.
“Due to this, key pharma companies have started the process to develop the drug’s raw material, the active pharmaceutical ingredients (APIs),” an industry source told ThePrint.