Remdesivir, one of two medicines thus far to be cleared for emergency use in the U.S. for COVID-19, appears to provide some level of benefit over standard of care for moderately ill patients, according to fresh clinical data released Monday by the drug's developer, Gilead Sciences.
The data show that patients who were put on a 5-day course of remdesivir were 65% more likely to have their condition improve after 11 days, compared to patients given the standard treatment for COVID-19, the disease caused by the novel coronavirus. To measure "clinical improvement," researchers used a 7-point scale that evaluated patients' condition, which ranged from not hospitalized, to requiring extensive care, to death.
The study also tested a 10-day remdesivir treatment course and found that, while the odds of improvement were "favorable," the benefit over standard of care wasn't statistically significant. Fewer people on remdesivir died or saw their condition worsen, although those results, too, didn't reach statistical significance.
Gilead said both courses of remdesivir were generally well-tolerated, with fewer patients experiencing serious side effects than those who got standard of care.
The new results help bolster findings from a National Institutes of Health-sponsored study, which found that remdesivir can help some patients with 'severe' disease recover from COVID-19 more quickly than they would otherwise.
The data also provide more insight as to which COVID-19 patients benefit the most from treatment. Remdesivir is meant to stop the coronavirus from replicating, leading researchers to believe it would have the greatest impact when administered earlier on, when COVID-19 symptoms aren't as severe. Patients in the study Gilead reported today had more moderate disease than those who were in the NIH-sponsored trial.
"These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients," said Francisco Marty, an infectious diseases physician at Brigham and Women's Hospital, in a June 1 statement from Gilead.
The NIH study found that hospitalized patients recovered four days faster when treated with remdesivir versus placebo — and that the benefits were most noticeable in patients who hadn't yet needed mechanical ventilation. The results led the Food and Drug Administration to clear remdesivir for emergency use last month.
A separate study run by Gilead in "severe" COVID-19 patients, meaning they were hospitalized and required supplemental oxygen at the time of screening, found little difference in effectiveness between the 5-day and 10-day remdesivir courses.
The latest data, however, should "further substantiate the use of 5-day remdesivir in all hospitalized patients," according to Piper Sandler analyst Tyler Van Buren. That's important given it will be easier for Gilead to manufacture and supply doses of the quicker regimen.
Phase 3 SIMPLE results
|5-day RDV n=191||10-day RDV n=193||SoC n=200|
|Efficacy at day 11|
|≥ 2-point improvement in ordinal scale||134 (70%)||126 (65%)||121 (61%)|
|≥ 1-point improvement in ordinal scale||146 (76%)||135 (70%)||132 (66%)|
|Requiring any oxygen support||12 (6%)||13 (7%)||22 (11%)|
|≥ 1-point worsening in ordinal scale||6 (3%)||12 (6%)||22 (11%)|
|Death||0||2 (1%)||4 (2%)|
|Any adverse event||97 (51%)||106 (55%)||90 (45%)|
|Grade ≥3 AE||20 (10%)||21 (11%)||24 (12%)|
|Any serious adverse event||8 (4%)||7 (4%)||18 (9%)|
SOURCE: Company release
Still, important questions linger.
"A fair amount of critical data has not been disclosed just yet," noted Umer Raffat, an analyst at investment bank Evercore ISI.
Specifically, Raffat pointed out that Gilead didn't disclose what kind of survival benefit remdesivir provided for patients beyond 11 days of follow-up. The analyst is also looking for details on when patients started to receive remdesivir after first showing symptoms, as well as the percentage of patients who improved enough to leave the hospital — which he points out was the trial's original goal. Gilead said it plans to publish the details from the study in a peer-reviewed journal "in the coming weeks."
Gilead investors may have been expecting more from Monday's data drop as well. Shares were down 4% by mid-morning, to trade a little under $75 apiece. Despite the dip, Gilead's share price is up about 15% since the start of the year, bolstered in part by the company's leading position in the race to develop COVID-19 treatments.