With Prime Minister Boris Johnson infected and isolated in Downing Street, and other top officials similarly afflicted with COVID-19, the U.K. is joining in the testing for Gilead Sciences' much-hyped antiviral candidate remdesivir.
The Big Biotech will launch a series of trial sites for its investigational broad-spectrum drug, originally designed to battle Ebola. As a nucleotide analog that mimics adenosine, one of the building blocks of any RNA virus’s genome, the therapy could also attack SARSCoV-2, the virus causing COVID-19—or so the theory goes.
Armed with the country's urgent public health research (UPHR) status, remdesivir w
ill now start two phase 3 trials—initially at 15 centers up and down the U.K.—to assess how well it can work in patients with moderate to severe COVID-19.
The COVID-19 numbers are grim across Britain: At the end of March, deaths were around 1,800 with 25,000 confirmed cases, even with testing mostly limited to hospitalized patients. Case counts have jumped by more than 300 each day as March came to a close.
To handle the surge,a major new hospital with more 4,000 beds has come online inside a London conference center and the government has enlisted British manufacturers, including automakers, to build a fleet of new ventilators.
Having a treatment in their arsenal would be a game-changer, and officials say they're ready to move quickly to test any likely prospects. Siu Ping Lam, M.D., director of the licensing division at U.K. drug regulator MHRA, said in the statement that the agency "is ready to prioritize and provide any assistance for clinical trials and other regulatory applications in response to COVID-19, in line with government priorities.
“We have procedures for rapid scientific advice, reviews and approvals and are ready to support manufacturers, researchers and other regulators. We have dedicated resources to ensure this happens, as we did during the Ebola crisis when we authorized clinical trial applications within a week.”
There are already three ongoing COVID-19 clinical trials at locations across China and the U.S. for remdesivir. Doctors in the U.S. have also treated patients with the drug under the Food and Drug Administration’s compassionate use policy, and Gilead recently announced plans to expand that access program to approve treatment for multiple patients at a time.