Remdesivir Shows Promise In COVID Patients In Leaked Report

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AChicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned.

https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/

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Early peek at data on Gilead coronavirus drug suggests patients are responding to treatment

By ADAM FEUERSTEIN @adamfeuerstein and MATTHEW HERPER @matthewherper

APRIL 16, 2020

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A vial of the remdesivir, an investigational drug from Gilead.GILEAD SCIENCES VIA AP

AChicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned.

Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease.

The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir. 

 

“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.

Her comments were made this week during a video discussion about the trial results with other University of Chicago faculty members. The discussion was recorded and STAT obtained a copy of the video.

 

The outcomes offer only a snapshot of remdesivir’s effectiveness. The same trials are being run concurrently at other institutions, and it’s impossible to determine the full study results with any certainty. Still, no other clinical data from the Gilead studies have been released to date, and excitement is high. Last month, President Trump touted the potential for remdesivir — as he has for many still-unproven treatments — and said it “seems to have a very good result.”

In a statement Thursday, Gilead said: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”

Gilead had said to expect results for its trial involving severe cases in April. Mullane said during her presentation that data for the first 400 patients in the study would be “locked” by Gilead Thursday, meaning that results could come any day.

Mullane, while encouraged by the University of Chicago data, made clear her own hesitancy about drawing too many conclusions.

“It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison. “But certainly when we start [the] drug, we see fever curves falling,” she said. “Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”

She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.

Related: 

Immunomedics halts late-stage clinical trial, confirming drug benefit for aggressive type of breast cancer

Reached by STAT, Mullane confirmed the authenticity of the footage but declined to comment further.

Asked about the data, Eric Topol, director of the Scripps Research Translational Institute, described them as “encouraging.”

“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,” he said, adding that it will be important to see more data from randomized controlled studies.

Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world. 

The trial is investigating five- and 10-day treatment courses of remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between. 

The lack of a control arm in the study could make interpreting the results more challenging. 

A lack of data has led to yo-yoing expectations for the drug. Two studies in China had enrollment suspended partway through because there were not enough patients available. A recent report of patients given the drug under a special program to make it available to those who are very ill generated both excitement and skepticism.

In scientific terms, all the data are anecdotal until the full trial reads out, meaning that they should not be used to draw final conclusions. But some of the anecdotes are dramatic.

Slawomir Michalak, a 57-year-old factory worker from a suburb west of Chicago, was among the participants in the Chicago study. One of his daughters started feeling ill in late March and was later diagnosed with mild Covid-19. Michalak, by contrast, came down with a high fever and reported shortness of breath and severe pain in his back.

“It felt like someone was punching me in the lungs,” he told STAT. 

STAT Plus: 

Exclusive analysis of biopharma, health policy, and the life sciences.

At his wife’s urging, Michalak went to the University of Chicago Medicine hospital on Friday, April 3. His fever had spiked to 104 and he was struggling to breath. At the hospital, he was given supplemental oxygen. He also agreed to participate in Gilead’s severe Covid-19 clinical trial. 

His first infusion of remdesivir was on Saturday, April 4. “My fever dropped almost immediately and I started to feel better,” he said. 

By his second dose on Sunday, Michalak said he was being weaned off oxygen. He received two more daily infusions of remdesivir and recovered enough to be discharged from the hospital on Tuesday, April 7. 

“Remdesivir was a miracle,” he said. 

The world is waiting to find out if it is really so.

About the Authors

Adam Feuerstein

Senior Writer, Biotech

Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street.

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Dow futures rally 900 points after report says Gilead drug showing effectiveness against coronavirus

PUBLISHED THU, APR 16 20205:13 PM EDTUPDATED 9 MIN AGO

 

Fred Imbert@FOIMBERT

 

 

 

 

 

 

WATCH NOW

VIDEO06:09

Gilead up on positive early data on Remdesivir and coronavirus

 

U.S. stock futures surged on Thursday night after a report said a Gilead Sciences drug was showing effectiveness in treating the coronavirus. The move pointed to a jump for the stock market on Friday.

Dow Jones Industrial Average futures were up 903 points, or about 3.9%. S&P 500 futures gained 3.4% while Nasdaq 100 futures were up by 2.6%.

 

Gilead shares jumped by 14% in after-hours trading after STAT news reported that a Chicago hospital treating coronavirus patients with Remdesivir in a trial were recovering rapidly from severe symptoms. The publication cited a video it obtained where the trial results were discussed.

close dialog

The top moments in business and politics - wrapped with exclusive color and context - right in you“This is obviously good news. Of course, we’ve heard a few other pieces of good news like this recently and they didn’t pan-out as well as people had hoped,” said Matt Maley, chief market strategist at Miller Tabak, in an email. “The big question is whether it’s going to be enough to help the economy ‘re-open’ more quickly than people are thinking right now.”

“To me, the critical issue is employment,” Maley added. “If the economy can bounce back quickly enough to take the unemployment rate back into the low-single digits quickly, that’s going to be very bullish.”

Other studies have shown Remdesivir to be an effective treatment against the coronavirus. However, they have been smaller in scale.

“An effective treatment is a huge deal and would create a path to open the economy and resume normal ‘social activities’ way sooner than a vaccine,” said Tom Lee, head of research at Fundstrat Global Advisors. “A treatment is safer and more scalable because it is only given to people who need to be treated.”

 

Boeing shares also jumped about 7% after the airplane maker said it would resume production in the Seattle area as early as April 20. 

Stocks tumbled from record highs in February into a bear market a month later as the spread of the coronavirus roiled market sentiment and the economic outlook. 

More than 2 million cases have been confirmed worldwide, including over 650,000 in the U.S., according to Johns Hopkins University. Governments urged people to stay home, effectively shutting down the global economy. 

However, the stock market has rallied since March 23 as new coronavirus cases in the U.S. and globally showed signs of plateauing. President Donald Trump said Thursday that “our experts say the curve has flattened and the peak … is behind us.” He also issued guidelines to open up parts of the U.S.

Since late March, the S&P 500 has jumped more than 25% while the Dow has gained 26.6% in that time. Stocks also got a boost after the Federal Reserve cut rates to zero and stabilized credit markets while Congress passed a stimulus plan. 

To be sure, the outbreak has already dealt a massive blow to the economy. In four weeks, about 22 million Americans have lost their jobs. Retail sales posted last month their biggest fall on record.

Some investors have also said that news of an effective treatment or vaccine would be needed for stocks to mount a sustainable comeback.

“If it is effective in keeping someone from contracting the virus or, more likely, simply reduces its severity, that would be a game changer and [would] allow the economy to restart both more quickly and more fully,” said Jim Paulsen, chief investment strategist at The Leuthold Group, about the Remdesivir trial report. 

—CNBC’s Yun Li, Pippa Stevens and Tom Franck contributed to this report.

https://www.cnbc.com/2020/04/16/sp-500-etf-jumps-2percent-after-hours-on-report-gilead-drug-showing-effectiveness-treating-coronavirus.html

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United States Patent	10,251,898
Chun ,   et al.	April 9, 2019

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Methods for treating Filoviridae virus infections
 

Abstract

Provided are compounds, methods, and pharmaceutical compositions for treating Filoviridae virus infections by administering ribosides, riboside phosphates and prodrugs thereof, of Formula IV: ##STR00001## The compounds, compositions, and methods provided are particularly useful for the treatment of Marburg virus, Ebola virus and Cueva virus infections.

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Inventors:	Chun; Byoung Kwon (Pleasanton, CA), Clarke; Michael O'Neil Hanrahan (Redwood City, CA), Doerffler; Edward (Foster City, CA), Hui; Hon Chung (Foster City, CA), Jordan; Robert (Foster City, CA), Mackman; Richard L. (Millbrae, CA), Parrish; Jay P. (El Dorado Hills, CA), Ray; Adrian S. (Burlingame, CA), Siegel; Dustin (San Carlos, CA)
Applicant:	Name City State Country Type Gilead Sciences, Inc. Foster City CA US
Assignee:	GILEAD SCIENCES, INC. (Foster City, CA)
Family ID:	54557474
Appl. No.:	15/902,690
Filed:	February 22, 2018   http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=2&f=G&l=50&co1=AND&d=PTXT&s1="CHUN+BYOUNG+KWON".INNM.&OS=IN/"CHUN+BYOUNG+KWON"&RS=IN/"CHUN+BYOUNG+KWON"