• Clinical trials so far have shown remdesivir helped at least 70% of patients who were treated intravenously
  • The new trials will involve a spray version of the drug, originally developed to treat SARS
  • O'Day said the key is to treat the disease before the body's inflammatory response takes over

The head of Gilead Sciences (GILD) on Monday outlined the company’s plans for phase 1 trials of its COVID-19 treatment remdesivir, saying the key to defeating the coronavirus pandemic is finding a method of treating the ailment in its early stages, before the body’s inflammatory response kicks in.

The coming round of studies will focus on a spray version of the antiviral drug originally developed to treat SARS that can be administered outside the hospital.

In a blog post on Gilead’s Innovation site, Chairman and CEO Daniel O’Day said the key will be finding the right combination of remdesivir dosage and anti-inflammatory drugs. Use of the drug at infusion centers also will be studied.

“We have been keen to explore how remdesivir might work when combined with anti-inflammatory agents, particularly in the most severely ill patients,” O’Day said.

A U.K. study released last week indicated dexamethasone, an inexpensive corticosteroid, reduced death rates in the sickest COVID-19 patients by a third.

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

The Food and Drug Administration is allowing remdesivir to treat hospitalized COVID-19 patients under an emergency use order. Patients receive the drug intravenously. Studies so far have indicated the drug is more useful earlier in the disease progression, before patients are put on ventilators, than in the later stages, but at least 70% of patients showed improvement.

O’Day said the company plans to have 2 million doses of remdesivir available by the end of the year and millions more available through 2021. The existing supply has been donated, and voluntary licensing agreements have been set up with nine generic manufacturers, he said.

The phase 1 studies are planned to begin in healthy volunteers this week and expand to COVID-19 patients in August. Clinical trials involving children began last week, and Gilead is cooperating with an external group to study the drug’s effect in pregnant women. A further trial is planned for people with end-stage renal disease.

“Based on our knowledge of the disease so far, it seems that in the earlier stages of COVID-19, the virus itself is the primary driver of illness. In the later stages, the body’s inflammatory response may cause some of the most life-threatening aspects of the disease,” O’Day said.

“It is important, therefore, to have tools that can work together to fight both aspects of the disease: an antiviral to target the virus itself and another therapy to tackle the inflammatory response.”

As of midmorning Monday, about 9 million coronavirus infections had been confirmed worldwide with nearly 469,000 confirmed deaths. In the U.S. nearly 2.3 million cases had been confirmed with about 120,000 deaths.

Gilead was trading down about 2.8% at $75.34.