Gilead Sciences Inc (GILD) has been working on an experimental coronavirus treatment, known as remdesivir, and has recently succeeded in a Phase 2 study. The report has shown a proven benefit in speeding up recovery time by 31%, compared to patients who received placebo. The results have also indicated an increased survival rate, namely, 11.6 percent for the placebo group versus 8 percent for the group that were administered remdesivir.
“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” said Dr. Anthony Fauci, the head of the National Institutes of Allergy and Infectious Diseases at the White House on Wednesday.
Remdesivir is not yet licensed or approved anywhere in the world, but Gilead has begun two Phase 3 clinical studies to determine the drug’s safety and efficacy in adults diagnosed with Covid-19.
President Donald Trump expressed his optimism regarding the drug in question by saying that he wants the FDA to rapidly authorize Gilead’s remdesivir as a coronavirus treatment.
Despite the President’s rush and a clear call to action, it is yet unclear whether the FDA would take immediate measures. An FDA official reportedly said, “the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.”
Once approved, Gilead plans to make the first 1.5 million vials of the coronavirus treatment for free. This represents around 250,000 five-day regimens of the drug.
At the same time, the outcomes of two other remdesivir studies released Wednesday seemed conflicting and less encouraging. Experts note that both studies had flaws, making results difficult to interpret and more research is needed.
In a press release Gilead Sciences indicated that the first study showed that patients who were given a 10-day treatment course of the drug “achieved similar improvement in clinical status compared with those taking a 5-day treatment course.”
The other study, published in The Lancet, found remdesivir had zero effect on reducing COVID-19 death rates, or even on making people recover faster.
The main flaw of the analysis is that it did not compare remdesivir to a placebo, so it’s impossible to determine whether any benefits were due to the drug or whether patients would have improved on their own.
What’s more, the Lancet study’s conclusion was turbid due to the fact that the research was stopped early. This was mainly because the investigators in Wuhan only managed to recruit half of the patients they had planned to study.
Gilead has promised that full results of the trial will be published in the coming weeks, as well as to provide further information on what that “improvement” means for patients.
Despite the current remdesivir controversy, GILD stock jumped 5.7%, following the positive statements made by President Trump and Dr. Fauci.