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Gilead to start testing inhaled remdesivir, eyeing earlier COVID-19 use

Gilead to start testing inhaled remdesivir, eyeing earlier COVID-19 use

Gilead Sciences’ infused antiviral remdesivir currently holds an FDA emergency use authorization to treat severe hospitalized COVID-19 patients. But the company is hoping a new formulation could get it into earlier stages of the respiratory disease.

The Big Biotech has won FDA clearance to start a phase 1 trial of an inhaled version of remdesivir in healthy volunteers, CEO Daniel O’Day said in an open letter Monday. The drug is currently given intravenously every day in the hospital.

The company’s intention is very clear: reaching patients earlier, before their disease worsens and becomes harder to treat. “An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of disease,” O’Day said.

So far, clinical trials have proven remdesivir’s benefits in hospitalized patients. In the NIH-run ACTT-1 trial, the drug showed it could cut the duration of hospital stay by a median of four days. As O’Day noted, remdesivir appeared to work best in patients who were not mechanically ventilated, which he said supports “further study in patients with earlier disease.”

What he didn’t mention was that the drug’s benefits actually decreased in mild or moderate patients—though that patient population was too small to be conclusive—just as it didn’t much help those critically ill patients on invasive ventilation. The company recently said in its own phase 3 Simple trial, moderate patients on remdesivir were 65% more likely to see their clinical symptoms improve than those on standard treatment alone.

But as Evercore ISI analyst Umer Raffat noted at the time, the ACTT-1 readout is still missing data on whether patients who take remdesivir soon after symptom onset fare better.

Getting an antiviral early to potentially stop disease progression is an appealing idea, and it will be the focus of Gilead’s next wave of clinical development. New studies will also test the IV formulation in the outpatient setting at places such as infusion centers and nursing homes.

“For patients who are at high risk of disease progression, it could be particularly beneficial to start treatment outside the hospital,” O’Day argued. “Our hope is that earlier intervention could help patients avoid hospitalization altogether.”

Another approach Gilead’s pursuing for remdesivir is a combination with anti-inflammatory drugs. The NIH is running the ACTT-2 trial, pairing remdesivir with Eli Lilly’s JAK inhibitor Olumiant. Another trial with Roche is adding remdesivir to the Swiss pharma’s IL-6 inhibitor Actemra. Data from those trials will read out “over the coming months,” O’Day said.

Now that industry watchers already understand remdesivir’s clinical profile—that it’s not a silver bullet—the focus is mainly shifting to how the company plans to price the drug once its donated existing supply runs out this month.

In the Monday statement, O’Day once again kept mum about Gilead’s pricing strategy, only repeating that the company “will work to ensure that remdesivir is accessible and affordable to governments around the world.”

Previously, U.S. drug cost watchdog the Institute for Clinical and Economic Review estimated that the drug should cost no more than $4,460 to be deemed cost-effective during a pandemic. Wall Street analysts generally viewed that price as fair.

Meanwhile, Gilead is also improving supply, now planning to offer 2 million courses of remdesivir this year, up from its previous estimate of around 1 million. It has so far penned licensing deals with nine generic drugmakers to ramp up supply, according to O’Day.

Jun 22, 2020

https://www.fiercepharma.com/

June 23, 2020 / Pharma News
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