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2020-04-29| COVID-19

COVID-19: Gilead’s Promising Remdesivir Data Jumps US Stocks, Hastens FDA’s Emergency Authorization Plans

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

The potential COVID-19 antiviral, remdesivir is said to have attained the primary endpoint in a US goverment-funded study, generating optimistic remarks from the US President Donald Trump and NIAID Director, Dr. Anthony S. Fauci. Gilead also released data from Phase 3, SIMPLE trial showing that a shorter duration of Remdesivir dosing is effective in patients. The news had an immediate impact on the US stock index futures sending the Dow Jones Industrial Average up by 500 points.

On April 29th, Wall Street witnessed a stock market jump following two promising news concerning the highly anticipated clinical trial results of experimental drug, remdesivir. At the White House meeting this morning, Dr. Fauci expressed optimism over the encouraging data from the study conducted by the National Institute for Allergy and Infectious Diseases (NIAID). “It is the first, truly high powered, randomized, placebo-controlled trial,” he said.

Earlier this week, the Data and Safety Monitoring Board approached the study team comprising of investigators from multiple trial sites throughout the world to notify that “remdesivir has a clear cut, significant, positive effect in diminishing the time to recovery,” a primary endpoint of the study. The time of recovery was significantly improved by 31% in patients treated with remdesivir as compared to placebo (11 days vs. 15 days). “It is a very important proof of concept,” said Dr. Fauci, expressing excitement. “What it has proven is that a drug can block this virus,” he added. He cautioned that the data would have to pass peer review, but the results have made him optimistic.

Remdesivir is not yet licensed or approved anywhere in the world. In an official statement, Gilead Sciences mentioned that it is aware of the actual data emerging from NIAID and would continue to follow the developments and discuss with regulatory authorities about the drug as a potential treatment for COVID-19.

 

Phase 3 SIMPLE Trial

Meanwhile, the pharmaceutical giant also announced results from the Phase 3 SIMPLE trial conducted in 397 hospitalized patients with severe COVID-19. The trial evaluated the 5-day and 10-day dosing durations of the drug and found that the efficacy between both regimens was comparable. The drug was well tolerated by patients, and no new safety concerns were identified in either treatment group.

“These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Prof. Aruna Subramanian, MD from Stanford University School of Medicine who is one of the lead investigators of the study.

While the 5-day treatment showed clinical improvement for 50 percent of patients in ten days, the 10-day treatment group achieved it in eleven. Around 60% of patients (120/200) in the 5-day treatment group and 52.3% (103/197) in the 10-day treatment group were discharged from the hospital by Day 14. Similar stats were observed in the number of patients who achieved a complete recovery. Gilead says that the clinical outcomes varied by geography. Outside of Italy, from a total of 320 patients, 64% recovered (205), and the mortality was 7 % (23) across both treatment groups.

Chief Medical Officer of Gilead Sciences, Merdad Parsey, MD, Ph.D., said that these study results complement data from the placebo-controlled NIAID study and help determine the optimal duration of treatment. “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. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care,” he added.

 

Contradicting Trial Results from China

Following today’s announcement, Gilead’s shares grew by 11% in early trading. Besides, it also impacted the performance indices of the stock market with the Dow Jones Industrial Average gaining over 500 points and the S&P 500 indices rising by 2.66%. However, several analysts criticize investors for relying too much on the clinical trial data of remdesivir.

So far, opposing conclusions have come from trials around the world. Among them, a study conducted in China draws special attention, since it suggested that remdesivir offered no statistically significant benefit in patients. The draft of the manuscript was accidentally uploaded to the World Health Organization website last week. Though it was taken down after some time, the document was quickly picked up by analysts and resulted in shrinking Gilead’s stock value. The full study was coincidentally published today in The Lancet journal. Nevertheless, the authors of the study were careful in interpreting the data. Although they claim “remdesivir was not associated with statistically significant clinical benefits,” they exercised caution by saying that the “numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.” This is because the trial had to be stopped early owing to the dwindling trial participants with severe COVID-19 cases in China.

 

FDA’s Plans for Emergency Authorization

The latest news of remdesivir’s benefit is sure encouraging, but a premature authorization cannot be ruled out at these times of desperation. At the meeting today, President Trump said that the new remdesivir trial data is positive, and he wants the USFDA to move “as quickly as they can.” “We would like to see very quick approvals, especially with things that work,” he said. According to the New York Times, the USFDA plans to announce an emergency-use authorization for remdesivir. If it does so, the drug would be the world’s first to be approved for COVID-19 by any regulatory agency.

 

References
  1. https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
  2. https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19
  3. https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-sciences-statement-on-positive-data-emerging-from-national-institute-of-allergy-and-infectious-diseases-study-of-investigational-antiviral-rem
  4. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext
  5. https://www.nytimes.com/2020/04/29/us/coronavirus-usa-cases-deaths.html

 

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