A small remdesivir study with lots of shortcomings suggests it may be working against Covid-19 — and 1 analyst forecasts mid-May rollout
In a small study involving 53 compassionate use cases of severely afflicted Covid-19 patients, Gilead found encouraging evidence that suggests remdesivir might be providing a benefit — but it all has to be borne out in ongoing Phase III studies.
Reporting in the New England Journal of Medicine, researchers concluded that the drug resulted in the clinical improvement of 68% of these patients, Gilead reports, but the caveats are extremely important. The study was small, data may be missing, and there was no randomized control group to compare against.
Still, Gilead reports:
After 28 days of follow-up, the cumulative incidence of clinical improvement, defined as discharge from the hospital and/or at least a two-point improvement from baseline on a predefined six-point scale, was 84 percent according to Kaplan-Meier analysis. Clinical improvement was less frequent among patients on invasive ventilation versus noninvasive ventilation (HR: 0.33 [95 percent CI 0.16, 0.68]) and among patients at least 70 years of age (HR vs < 50 years: 0.29 [95 percent CI 0.11, 0.74]).
Summarized by SVB Leerink analyst Geoffrey Porges:
Of the 30 patients who had been intubated and ventilated, 6 (18%) died and 24% had been discharged. 47% of all patients in the study had been discharged and the cumulative incidence of clinical improvement at 28 days of follow-up was 84%….Of the 19 hospitalized patients who were receiving supplemental oxygen, 1 (5%) died and the vast majority of the rest (17) had been discharged. By comparison, we would have expected a mortality of ~50-90% among the ventilated patients and 5-10% among the non-ventilated, (non ICU) oxygen supported patients, improvement in outcomes of 20% that we had been expecting, and is likely to offer considerable relief to physicians, patients and investors.
While some groups will likely push for an immediate approval to start using remdesivir, Porges thinks that Gilead will still likely wait for better data — with the first round from China due any day now. But the analyst thinks this one is likely to be good to go for at least limited use by mid-May.
Perhaps of equal importance, the researchers involved said that there were no new safety issues to be seen from earlier trials in another indication. A clean safety profile will be crucial to a snap approval from the FDA and EMA, at a time new drugs are desperately needed.
In normal circumstances, this would be the kind of data that most researchers would shrug off as perhaps interesting and suggestive of better things to come, but of no real importance. But these aren’t normal times.
“While the outcomes observed in this compassionate use analysis are encouraging, the data are limited,” said Merdad Parsey, the CMO Gilead Sciences. “Gilead has multiple clinical trials underway for remdesivir with initial data expected in the coming weeks. Our goal is to add to the growing body of evidence as quickly as possible to more fully evaluate the potential of remdesivir and, if appropriate, support broader use of this investigational drug.”
Remdesivir is the most advanced of all the antivirals now being hustled through a rapid set of pivotal studies, and any proof one way or the other is being studied with unprecedented intensity in a world fearful of the impact of the worst outbreak in living memory.
The news quickly attracted a few key thumbs up. Eric Topol, founder and director of the Scripps Research Translational Institute in La Jolla, in particular noted one key sentence in the NEJM:
It is notable that 17 of 30 patients (57%) where were receiving invasive mechanical ventilation were extubated, and 3 of 4 patients (75%) receiving ECMO stopped receiving it; all were alive at last followup.
Big for #COVID19 therapy: the compassionate use results for remdesivir in 53 patients looks very encouraging, especially in very sick patients on mechanical ventilation with 18% fatality (only, expect > 50%) and overall 68% improvement https://t.co/oP8eDK6jYL @NEJM pic.twitter.com/9kisPxy1un
— Eric Topol (@EricTopol) April 10, 2020
For a look at all Endpoints News coronavirus stories, check out our special news channel.