Preliminary data from a National Institutes of Health-sponsored Phase III study of a closely watched drug being developed for Covid-19 showed that patients who received it recovered from the disease faster than those who received placebo.
The National Institute of Allergy and Infectious Diseases said Wednesday that the early data from the 1,063-patient Adaptive Covid-19 Treatment Trial, or ACTT, indicated that patients who received Gilead Sciences’ remdesivir recovered 31% faster than those in the placebo group, with respective median recovery times of 11 and 15 days. The results overall were statistically significant. There was also suggestion of a survival benefit, with respective mortality rates of 8% and 11.6% in the remdesivir and placebo arms, though that result missed statistical significance, with a p-value of 0.059. NIAID said more data would be available in a forthcoming report.
The announcement comes just hours after the Foster City, California-based company announced data from its own Phase III study in patients with severe disease showed similar efficacy between five- and 10-day treatment regimens. However, that study lacks a control arm, making interpretation difficult. The company had also said it had received word from NIAID that the institute’s trial was positive, but without details on the data. Importantly, the ACTT study was a randomized, controlled trial with a placebo arm, making its results easier to interpret.
Shares of Gilead were up 6% on the Nasdaq in afternoon trading following the NIAID news.
Also on Wednesday, British medical journal The Lancet released results of a Chinese trial that had been terminated early and produced a negative result, per data that had been prematurely posted on the World Health Organization’s website. However, that trial had been stopped early due to difficulty enrolling patients, making its results also difficult to interpret.
In a note to investors, Cowen analyst Phil Nadeau wrote that the NIAID study data suggest remdesivir is active and will have a role in treatment, but more data are needed to define its profile. Citing an interview with a physician, Nadeau wrote that the drug likely has a moderate and not dramatic benefit in the time to disease recovery and progression of the disease, particularly for those treated early, no more than 10 days from the onset of symptoms. With no approved therapies on the market, the drug will likely become a first-line therapy for hospitalized patients, he added.
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