New Gilead remdesivir data likely enough for speedy FDA approval: Jefferies

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As investors and much of the world await any glimmer of hope for treating the ongoing coronavirus pandemic, it shouldn’t be much of a surprise that Gilead Sciences' shares rocketed up on word that one key trial was positive and details were out in another for severe patients.

First, to the data we do know, which are from a Gilead study essentially trying to help guide its path for treatment: To put it lightly, this is not a normal way to assess a drug’s efficacy, but these are not normal times. There was no control arm in the open-label, phase 3 test, known as SIMPLE, and the test was set up to see whether a shorter, five-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen, which is being used in a series of ongoing studies of the drug.

Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups. Patients were required to have evidence of pneumonia and reduced oxygen levels that did not require mechanical ventilation at the time of study entry.

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Clinical improvement was defined as an improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support to death.

The data read like this: The time to clinical improvement for half of patients was 10 days in the five-day treatment group and 11 days in the 10-day treatment group.

Gilead said that more than half of patients in both treatment groups were discharged from the hospital by two weeks, and at Day 14, 64.5% (129 out of 200) of patients in the five-day treatment group and 53.8% (10 out of 197) of patients in the 10-day treatment group “achieved clinical recovery.”

These clinical outcomes, however, varied by geography. Outside of Italy, one of the worst affected countries in terms of mortality, the overall death rate at Day 14 was 7% (23 out of 320) across both treatment groups, with 64% (205/320) of patients experiencing clinical improvement at Day 14 and 61% (196/320) of patients discharged from the hospital.

Gilead also found that earlier treatment appeared to have better outcomes: “These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, M.D., clinical professor of medicine and chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study.

“While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”

Gilead acknowledges the complexities of assessing this med itself, with its Chief Scientific Officer Merdad Parsey, M.D., Ph.D., saying: “Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug.”

But he said results from this test “will help to determine the optimal duration of treatment with remdesivir.”

Separately, Gilead also announced that the drug had met its primary endpoint in a National Institute of Allergy and Infectious Diseases (NIAID) adaptive, randomized, double-blind, placebo-controlled trial that sought to assess the safety and efficacy of remdesivir in hospitalized adults diagnosed with COVID-19.

The primary endpoint was time to recovery. We have no details yet, but a brief update from Gilead notes the positive outcome. This is a much bigger deal as it suggests patients are responding to treatment with the experimental therapy, though we’ll have to await a breakdown before assessing its impact.

“Gilead Sciences is aware of positive data emerging from the National Institute of Allergy and Infectious Diseases' (NIAID) study of the investigational antiviral remdesivir for the treatment of COVID-19,” it said in a statement put out this morning just ahead of its SIMPLE data.

This NIAID test was in moderate to severe critical patients and a broader population, not just severe patients.

“We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.” It says it is continuing “to discuss with regulatory authorities the growing data set regarding remdesivir as a potential treatment for COVID-19.”

Shares in Gilead shot up 10% on the news Wednesday morning before settling to around 5%.

Analysts at Jefferies said that, while no data have yet been revealed, the news “confirms positive results that met the efficacy endpoint (improved time to recovery)” in a very large test (as it has more than 1,000 patients).

They also note its importance given that it has been randomized with a placebo to “truly compare” rather than the “one-off open-label and uncontrolled studies that have been coming out in the news recently and those were just anecdotal or no comparator arm.”

Jefferies thinks the FDA “will probably accelerate some sort of approval or expanded use” for the drug given the data.

The firm was less excited about the SIMPLE data, saying simply: “In short: the data look fine and consistent w/ other anecdotal data but is inconclusive in our view since there is no placebo.”

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