After trials began in China evaluating the efficacy of Gilead’s experimental antiviral drug remdesivir against the novel coronavirus earlier this month, the National Institutes of Health has initiated testing of the drug in the US.
The drug, which health experts from the World Health Organization (WHO) said is one of the most promising candidates against the virus, is currently being studied across two trials in China, the epicentre of the outbreak.
According to a statement issued by the NIH, the first trial participant is an American who was repatriated from the Diamond Princess cruise ship that docked in Yokohama, Japan.
Participants in the study, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), must have a laboratory-confirmed case of novel coronavirus – also known as COVID-19 – as well as evidence of lung involvement. That includes rattling sounds when breathing with a need for supplemental oxygen, abnormal chest X-rays or illness requiring mechanical ventilation.
The NIH will not be including patients with confirmed cases of COVID-19 who have only mild symptoms in the study.
“We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” said Anthony Fauci, NIAID Director and US Coronavirus Task Force member.
“A randomised, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients,” he added.
Prior to the novel coronavirus outbreak, Gilead was evaluating remdesivir as a treatment for Ebola virus disease, but since the drug has also shown promise against other types of coronavirus – namely MERS and SARS – it has been in the global spotlight as the first potential treatment for COVID-19.
Speaking at a press conference in Beijing, assistant director-general of the WHO Bruce Aylward said: “There is only one drug right now that we think may have real efficacy and that’s remdesivir.”
The two clinical trials in China are currently enrolling patients, with a Gilead spokesman confirming to CNN that the company expects results in April.
Although shares in the pharma giant have steadily climbed on the back of the remdesivir developments, bringing the drug to market and seeing a significant financial return could prove difficult for Gilead.
Despite Gilead filing a patent in China for the use of remdesivir against all coronaviruses back in 2016, this has not yet been issued.
Even more distressing, perhaps, for the US pharma company is the patent challenge from a team of Chinese scientists who allege they have improved and targeted the drug’s use against COVID-19, and who have now filed for a patent in China.
Chinese pharma company BrightGene also entered the mix after reporting earlier this month that it had successfully copied remdesivir, and has begun manufacturing the generic version.
However, despite the challenges, experts have maintained that Gilead’s patent is strongest.
“The Gilead patent is much much stronger,” Ana Santos Rutschman, of the Center for Health Law Studies at St. Louis University School of Law, told The Mercury News.
“Unless there is something fundamentally different about the second one, I would find it very hard for the Chinese institute to have a working drug without using Gilead’s technology,” she added.