Full NIH Data on Remdesivir Supports Early Positive Report

NIH Friday confirmed preliminary remdesivir trial data showing that the drug delivered a median recovery time of 11 days compared with 15 on placebo, establishing it as the standard of care for patients with moderate to severe disease.

“The group that showed the most benefit were those who needed oxygen but were not (or not yet) on ventilators. But this was also the largest group in the study, so further data may be needed in the other subgroups to clarify the effect,” says Lindsay McNair, WCG Clinical’s chief medical officer.

The National Institute of Allergy and Infectious Diseases (NIAID) responded to multiple requests for the full preliminary results of its international trial of 1,063 hospitalized patients in the New England Journal of Medicine. The preliminary data confirm topline findings the NIH announced on April 29.

The findings support remdesivir as the standard therapy for patients hospitalized with COVID-19 and requiring supplemental oxygen therapy, the NIH said. But the researchers said that antivirals need to be assessed along with other therapeutic agents to improve clinical outcomes, as they encountered a mortality rate of 7.1 percent at 14 days.

“[G]iven high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient,” they said.

The NIH began a separate arm of the trial on May 8 to study the use of remdesivir in combination with Eli Lilly’s anti-inflammatory drug baricitinib.

The research community is clamoring for release of all trial data from potential COVID-19 treatments. In a letter last week, Mihael Polymeropoulos, CEO of Vanda Pharmaceuticals, called for full disclosure of the remdesivir study data, saying it could help address unanswered questions and inform who should receive the limited-supply antiviral.

Vanda has skin in the game, as it is currently conducting a phase 3 trial of Eli Lilly’s  experimental drug trapiditant as a potential COVID-19 treatment and has partnered with the University of Illinois at Chicago to identify antivirals.

“Is there a subgroup of patients that performed better than others? Is this subgroup of a certain characteristic, such as age, sex, race, genetic makeup, time since infection, severity of disease, viral load, medication, underlying condition? And there are many others to be answered,” he said.

The pharma executive argued that while states may be inclined to give the drug to the most severe patients first because of the FDA’s Emergency Use Authorization (EUA), that approach could be misguided if the raw data showed the antiviral works better when given shortly after infection or when taken by less severely infected patients.

The NIH researchers said their preliminary findings “highlight the need to identify Covid-19 cases and start antiviral treatment before the pulmonary disease progresses to require mechanical ventilation.” But they said sicker patients also responded well to remdesivir.

Polymeropoulos said the raw data could potentially steer designs for therapeutic programs, and answer if a patient’s viral load is associated with their response to the drug, a question of “critical importance,” he said. He also called for the release of data from Gilead Sciences’ phase 3 remdesivir  trial (DID, April 30).

Access the NIH’s preliminary trial resultshere: www.fdanews.com/05-25-20-RemdesivirCOVID19PreliminaryReport.pdf.

Read the letter from Mihael Polymeropoulos here: www.fdanews.com/05-22-20-Letter.pdf. — James Miessler