Gilead Sciences Inc.’s experimental drug remdesivir met the main goal in a closely watched government-funded clinical trial treating hospitalized COVID-19 patients but another study, also disclosed on Wednesday, found that the therapy did not led to clinical improvement in patients in China.
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 217,000. 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, and the federal agency is expected to provide additional information about that trial. The primary outcome in this trial is recovery by 29 days of treatment, according to the study’s listing on ClinicalTrials.gov.
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.”
Dr. Anthony Fauci, the NIAID’s director, told reporters at the White House that the results “don’t seem like a knockout,” though he noted that “it is a very important proof of concept.”
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.
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 SPX, 2.72% is down 11.3%.
Originally Published on MarketWatch
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