Following US, China hospital efforts, Gilead plots its own PhIII trials for closely watched Covid-19 drug
Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.
Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.
The news also came on the day that the number of new cases reported outside China officially surpassed that inside. The virus dubbed SARS-CoV-2 has now spread to at least 44 other countries, including Brazil and Algeria.
Since Gilead dusted it off in late January, remdesivir — a drug originally developed for Ebola — quickly emerged as a frontrunner in the race to find an effective treatment for respiratory disease caused by SARS-CoV-2. After reporting promising in vitro data, scientists from the Wuhan Institute of Virology even tried to patent the drug while BrightGene said it’s mass producing the active pharmaceutical ingredient.
Chinese officials announced on Thursday that Gilead has been granted three of the eight patents it’s filed for since 2011, though the one specifying the use in coronaviruses is still under review.
Several hospitals in China have initiated clinical studies with donated drug and scientific input from Gilead. The first results are expected in April, despite stringent requirements that reportedly slowed down enrollment.
“Gilead’s primary focus is on rapidly determining the safety and efficacy of remdesivir as a potential treatment for COVID-19, and this complementary array of studies helps to give us a more expansive breadth of data globally on the drug’s profile in a short amount of time,” Gilead CMO Merdad Parsey said in a statement.
The Gilead studies will evaluate two dosing durations — 5 or 10 days — of remdesivir. One trial is designed for 600 patients with severe clinical manifestations, who will be given the drug in addition to standard of care; the other will involve 400 moderate patients and compare the treatment to standard of care. Normalization of fever and oxygen saturation will be the key metric for the first while the second will primarily measure proportion of patients discharged.