By Jaimy Lee
Gilead Sciences Inc.’s experimental drug remdesivir met the main goal in a closely watched government-funded clinical trial treating hospitalized COVID-19 patients, garnering support from officials who said the drug will be the standard of care. But a separate study, also disclosed on Wednesday, found that the therapy did not lead to clinical improvement in patients in China.
Shares of Gilead /zigman2/quotes/210293917/composite GILD 0.00% were up 5% in trading on Wednesday following two remdesivir-related news announcements from the drugmaker, the release of a preliminary data analysis by a government agency, and the publication of the China study in The Lancet.
Remdesivir is widely considered to be a front-runner among the investigational therapies being tested as treatments for infections caused by the novel coronavirus, which has sickened more than three million people and killed at least 219,000 people. There are no proven treatments or vaccines.
Of most interest to analysts and researchers is a National Institute of Allergy and Infectious Diseases (NIAID) clinical trial evaluating remdesivir in hospitalized COVID-19 patients, primarily because it has a placebo-controlled arm, while a Gilead-sponsored Phase 3 trial in severely ill patients does not. Gilead said in a statement on Wednesday that remdesivir met the study’s primary endpoint, which is defined as recovery by 29 days of treatment, according to the study’s listing on ClinicalTrials.gov. Time to recovery is a metric often used in clinical trials for influenza treatments, the federal agency said.
The NIAID said Wednesday afternoon that a preliminary data analysis of the trial data from 1,063 patients found patients taking the drug recovered 31% faster than those taking the placebo. In remdesivir patients, the median time to recovery was 11 days. In placebo patients, it was 15 days.
Dr. Anthony Fauci, the NIAID’s director, told reporters at the White House that remdesivir had “a clear cut significant positive effect in diminishing the time to recovery.” He said the mortality rate was lower in the remdesivir group (8%), when compared with those taking the placebo (11%), noting that it’s not yet a statistically significant finding. However, he further cemented his support for the remdesivir data, saying “this will be the standard of care.”
Analysts said that while the data is promising, additional details are needed to better determine remdesivir’s efficacy. “It seems like remdesivir is active and has a favorable impact in COVID-19,” Mizuho Securities analyst Salim Syed wrote in an investor note. “We still don’t know the details around the NIAID trial’s results, and this will be the next key question.”
Gilead also said a company-sponsored open-label Phase 3 trial testing the therapy in 6,000 severely ill patients found that those taking a 5-day or 10-day course of treatment led to similar results. At least 52% of participants taking either dosing regimen were discharged from the hospital after 14 days of treatment, and at least 53% of those patients were reported as reaching “clinical recovery.”
“Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19,” Gilead chief medical officer Merdad Parsey said in a statement. “The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir.”
Despite excitement around the top-line data shared by Gilead, data from the randomized, double-blind, placebo-controlled, multi-site trial in China published in The Lancet found that the drug was “not associated with statistically significant clinical benefits.” However, the 158 patients taking remdesivir (79 were on placebo) reported a quicker recovery, though researchers said that data point “requires confirmation in larger studies.”
The early findings may set the stage for the closely watched drug to move toward a possible emergency use authorization or approval from the U.S. Food and Drug Administration. The drug is currently being used on an expanded use or compassionate use basis. RBC Capital Markets’ Brian Abrahams wrote the data suggests that remdesivir is “likely approvable” among certain COVID-19 patients.
Gilead’s stock has had a turbulent few weeks as media outlets have reported on leaked data, both positive and negative, from some of the many clinical trials under way evaluating the drug.
“We continue to view the product as having very modest economic value to Gilead, given pricing and margin expectations,” SVB Leerink’s Geoffrey Porges wrote. “The potential value contribution increases if there are indications that COVID-19 will be a prevalent infection with seasonal characteristics similar to influenza.”
Gilead’s stock has gained 21.0% year-to-date, while the S&P 500 /zigman2/quotes/210599714/realtime SPX +1.60% is down 11.3%.