Report On Bay Area Biotech’s Coronavirus Drug Stirs Hope

FOSTER CITY, CA — Finally, a small piece of good news in the frantic pursuit of a viable treatment for the new coronavirus has emerged, and a Peninsula biotech firm is at the center of it.

An antiviral medication developed by Foster City-based Gilead Sciences has shown promise in a clinical trial administered by University of Chicago, according to a report in STAT News published Thursday.

STAT News cited comments made by a doctor leading the study in a conference recorded on video obtained by the publication.

Remdesivir, developed by Gilead in 2014 to treat Ebola, has been repurposed as a potential COVID-19 treatment option.

The University of Chicago study included 125 infected patients, of which 113 had severe cases. Infectious disease specialist Kathleen Mullane, who is leading the study, painted an encouraging picture of the study in the video STAT News obtained.

“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” Mullane said in comments not intended to be made public.

The report sparked a rally on Wall Street Friday, with the Dow Jones climbing 3%. The S&P 500 was up 2.68% and the Nasdaq 1.38%. Shares of Gilead were up nearly 10%.

Remdesivir is not a cure and hasn’t been represented as such, but the antiviral has been in the spotlight since February, when Bruce Aylward of the World Health Organization said it offered the best hope for treating COVID-19.

“There’s only one drug right now that we think may have real efficacy,” Aylward said. “And that’s remdesivir.”

Remdesivir has been used in clinical tests on animals with encouraging results treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), both of which are caused by other coronaviruses.

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Mullane confirmed the authenticity of the video to STAT News but declined to comment when reached by the publication.

In a statement to the publication University of Chicago Medicine said “drawing any conclusions at this point is premature and scientifically unsound.”

University of Nebraska is leading a randomized, controlled clinical trial to evaluate the safety and efficacy of remdesivir.

Dr. Angela Hewlett, the medical director of the bio-containment unit at University of Nebraska that's conducting the study, said in an interview with 60 Minutes that remdesivir doesn’t attack the virus itself, but rather obstructs its ability to reproduce.

“It inhibits replication of the virus, and so when a virus would normally try to reproduce itself, this drug inserts itself into that process and then stops viral replication, and so it stops reproduction of the virus,” Hewlett said.

STAT News noted that The University of Chicago study didn’t include a control group, in which some participants receive a placebo, making the results difficult to interpret.

Nevertheless, Eric Topol, director of the Scripps Research Translational Institute, told STAT News the results were “encouraging,” but said he’d like to see more data from a study that includes a control group.

“The severely hit patients are at such high-risk of fatality. So if it’s true that many of the 113 patients were in this category and were discharged, it’s another positive signal that the drug has efficacy,” Topol said.

Gilead has not been approved by the FDA as a safe and effective treatment for the coronavirus, but it has nevertheless ramped up production in anticipation of getting a thumbs up from the agency.

Former FDA Commissioner Dr. Scott Gottlieb told CNBC that the agency could consider making the drug available through emergency use authorization or accelerated approval, Benzinga reports.

President Trump falsely claimed in a March 19 news conference that remdesivir and hydroxychloroquine were “essentially approved for prescribed use,” which he described as a “tremendous breakthrough.”

FDA Commissioner Stephen Hahn said at the news conference that that wasn’t the case.

Some biotechnology analysts question whether Wall Street overreacted to the report.

“We would have thought that kind of reaction would have been reserved for positive clinical trials,” Cantor Fitzgerald analyst Alethia Young wrote according to a report in Barron’s.
Gilead issued a statement to Barron’s expressing guarded optimism.

“Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19,” a Gilead spokesman said.