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Gilead Sciences Inc. unveiled topline data on 1 June from a Phase III study of its antiviral remdesivir in moderately ill COVID-19 patients that increase the evidence suggesting the drug can offer a treatment benefit, but at the same time raise as many questions as they answer.

The data from the 584-patient SIMPLE study add to findings from a placebo-controlled study run by the US National Institute for Allergy and Infectious Diseases and Gilead’s own Phase III SIMPLE-study in severely ill patients indicating that the nucleotide analog can help patients already sick with the novel coronavirus. (Also see "Gilead's Remdesivir Results Encouraging, Safety Brings Skepticism" - Scrip, 29 Apr, 2020.) The drug is approved to treat the virus in Japan and is available in the US under a Food and Drug Administration emergency use authorization (EUA); it still needs to go through the standard FDA approval process for US market access beyond the duration of the EUA. (Also see "After Remdesivir's Emergency Use Authorization, US Gov't Must Now Decide How To Distribute Limited Supply" - Pink Sheet, 1 May, 2020.)

The SIMPLE study of moderately ill subjects tested five- and 10-day courses of remdesivir therapy on top of standard of care against standard of care alone – randomized 1:1:1 – in patients with confirmed COVID-19 and evidence of pneumonia but without reduced levels of oxygen. It was basically identical to Gilead’s study in severely ill COVID-19 patients – both were open-label studies without placebo control. NIAID’s Adaptive COVID-19 Treatment Trial (ACTT) measured time to recovery using the antiviral compared to placebo. (Also see "More Remdesivir Data, More Questions Linger" - Pink Sheet, 28 May, 2020.)

The study of moderately ill patients assessed their health at 11 days following the start of treatment, whereas the study in severely ill patients assessed its endpoint at 14 days. Gilead initially planned a 14-day assessment of the primary endpoint in both studies, but a company spokesperson indicated the protocol change was due to researchers’ growing understanding of the novel coronavirus and its effects.

“The endpoint was changed from day 14 to day 11 to enable assessment of clinical improvement at an earlier time point in patients with less severe disease,” the company said in an email.

Five Days Outperforms 10 Days Of Therapy

In moderately ill patients, the SIMPLE study found that patients receiving a five-day course of remdesivir were 65% more likely to show clinical improvement of at least one points – as measured on a seven-point scale ranging from hospital discharge to death – than patients receiving standard of care (p=0.017). Of 191 patients in the five-day treatment arm, 146 (76%) improved by one point or more on the ordinal scale, compared to 70% (135/193) in the 10-day treatment arm and 66% (132/200) on SOC.

On other measures, the five-day treatment arm yielded a two-point or greater improvement in 70% of patients, compared to 65% of those getting 10 days of treatment and 61% getting SOC. Eleven percent of patients getting SOC needed oxygen support at some point during treatment, compared to 6% on the shorter course and 7% on the longer course of remdesivir. Eleven percent of patients on SOC worsened by one point or greater, compared to 3% on the five-day treatment course and 6% on the 10-day course. There were four deaths in the SOC arm, two in the 10-day arm and none in the five-day arm.

Analysts generally noted that these data provide additional evidence that remdesivir can yield clinical improvement in COVID-19 patients but called the benefit modest and said the lesser results for 10 days of treatment were confounding. Gilead said it will submit the full dataset to a peer-reviewed medical journal for publication in upcoming weeks.

“The data reinforces our view that remdesivir is a reasonably effective drug in some patients, and thus has a role in the treatment of COVID-19, but also that it is not perfect and opportunity remains for alternatives,” BMO Capital Markets analyst Matthew Luchini said on 1 June. He added that since the SIMPLE studies were open-label, unlike the NIAID study, it is harder to draw definitive conclusions from the Gilead-run trials.

Sun Trust Robinson Humphrey analyst Robyn Karnauskas pointed out that the safety data were consistent with the previous studies. But several analysts said that makes it harder to understand why a 10-day course of remdesivir would not show better results than a five-day duration. Jefferies analyst Michael Yee noted that grade 3 adverse events and serious adverse events occurred more frequently with standard of care than either arm of study drug, “which is important of course.”

In his 1 June note, Yee called the data “modest,” saying they add incrementally “to a broader utilization of the drug into a more moderate population inside the hospital, but consensus already understands remdesivir is not a silver bullet.”

“We’d like more color as to why [the 10-day treatment arm] did not do as well as the five-day treatment group,” wrote Credit Suisse analyst Evan Seigerman on 1 June, adding the hope that publication of the full dataset might clarify the issue.

Morningstar analyst Karen Andersen called the study’s mortality data “difficult to assess” in a 1 June note, “given the strong outcomes for the vast majority of these moderately ill patients, and therefore lower number of deaths.”

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