Health & Fitness

Peninsula Biotech's Coronavirus Drug Impresses In Trials: Report

Remdesivir, an experimental drug developed by Gilead Sciences, has shown promise as a potential COVID-19 treatment in clinical trials.

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.
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. (Shutterstock / Corona Borealis Studio)

FOSTER CITY, CA - An antiviral medication developed by a Peninsula biotech company got a measured endorsement Tuesday as a potential treatment for the new coronavirus.

Remdesivir, developed by Gilead in 2014 to treat Ebola, has been repurposed as a potential COVID-19 treatment, and the early returns from two clinical trials are encouraging, US News and World Report reports.

Dr. Katherine Perez, an infectious disease pharmacist at Houston Methodist Hospital who is co-leading the trials of Foster City-based Gilead’s remdesivir, said the experimental drug has shown promise, the report said.

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"Early results are promising, and that is important right now,” Perez said. “Much of what we are learning about COVID-19 management is centered around preventing quick deterioration. Timing is everything. I can't say for certain they [patients] would have been intubated otherwise, but it's encouraging."

Houston Methodist Hospital is among five sites in the United States conducting clinical trials of remdesivir, the report said. The hospital is conducting separate trials, one for patients with moderate levels of COVID-19 illness and the other for those severely sickened.

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Perez’s comments followed the release of a video by STAT News showing University of Chicago clinicians heading a remdesivir trial talking up the experimental medication.

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%.

The report’s impact on Wall Street drew a call for a Securities and Exchange Commission probe from Texas congressman Lloyd Doggett according to a CNN report.

Gilead spokesman Chris Ridley told CNN the Peninsula biotech wasn't involved in the leak.

"Gilead had nothing to do with the information sourced by STAT from an internal recording out of the University of Chicago hospital," Ridley wrote to CNN in an email.


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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.

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.

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.


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