Gilead Starting Human Trials of an Inhaled Version of Remdesivir

A vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in March 2020. Gilead Sciences/AP

Gilead Sciences will begin human trials of an inhaled version of remdesivir this week.

“An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of the disease,” said Daniel O’Day, the Chairman and the CEO of Gilead Sciences in an open letter on June 22.

Gilead’s investigational drug, remdesivir, is currently administered in hospitals through daily infusions.

O’Day said the inhaled version of the remdesivir can play an important role in stopping the spread of the pandemic.

“We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 in August,” he said.

The Food and Drug Administration issued an emergency use authorization of the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 cases on May 1.

“FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives,” HHS Secretary Alex Azar had said in a statement.

The emergency use authorization of remdesivir allows it to be distributed across the country, administered intravenously in confirmed cases of the CCP (Chinese Communist Party) virus, the novel coronavirus that causes the COVID-19 disease.

O’Day said in a short period of time researchers at Gilead have learned a lot about how remdesivir works but there is “still some way to go” in exploring the full potential of the drug against the CCP virus.

“As part of our next wave of clinical development, we will study remdesivir in treating earlier in the disease, in combination with other therapies,” as well as additional patient groups said O'Day.

Vials of investigational COVID-19 treatment drug remdesivir are capped at a Gilead Sciences facility in La Verne, Calif., on March 18, 2020. Gilead Sciences/Reuters

Studies About Remdesivir

O'Day said that many random controlled trials of the drug “have been evaluating its safety and efficacy in hospitalized patients.”

The study on remdesivir done in the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, showed that the drug shortened the recovery time by an average of four days. This study had inrolled 1,063 patients at 47 sites in the United States and 21 international sites.

Gilead has also conducted a SIMPLE study on moderately ill patients that showed patients on a five-day course of the drug had better clinical outcomes.

“The inhaled formulation studies are one means of exploring the use of remdesivir in the earlier stages of COVID-19. We will also conduct trials using intravenous infusions in outpatient settings such as infusion centers and nursing homes,” said O'Day.

However, the drug is still not licensed or approved anywhere in the world, according to an earlier statement by Gilead.

“At the request of treating physicians. and with the support of local regulatory agencies, who have weighed the risks and benefits of providing an experimental drug with no data in 2019-nCoV, Gilead has provided remdesivir for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options,” said the company.

Research on the drug was first started by Gilead in 2009 with research programs for the treatment of hepatitis C (HCV) and respiratory syncytial virus (RSV) and its antiviral profiling was done in 2013 and early 2014—that suggested its broader antiviral potential.

The drug was also used in the treatment of Ebola but was discontinued after “two other investigational treatments in the trial were associated with greater survival,” said Gilead in an earlier release (pdf).