BioPharma

Gilead hopes to start inhaled remdesivir trial in healthy volunteers in August

In an open letter, Gilead CEO Daniel O'Day wrote that the company plans to start screening participants for the Phase I study program starting this week. The biotech company also plans to test intravenous remdesivir in outpatient settings.

Clinical development will soon begin for an inhaled version of an antiviral drug used to treat Covid-19 that is currently available only to hospitalized patients in intravenous form.

In an open letter posted on the company’s website, Gilead Sciences CEO Daniel O’Day wrote that the Foster City, California-based biotech firm would begin screening healthy volunteers this week for Phase I studies of an inhaled formulation of remdesivir. The company aims to begin the trials themselves in August.

Shares of Gilead were down 2.6% in mid-morning trading Monday on the Nasdaq.

The inhaled version of remdesivir would be given through a nebulizer, which O’Day wrote would potentially allow for easier administration outside the hospital and at earlier stages of the disease.

“We have learned a lot about how remdesivir works in a relatively short space of time,” O’Day wrote. “All of us at Gilead are grateful for the strong collaborations that helped to make this possible and to the thousands of patients who have taken part in clinical trials.”

The intravenous formulation of remdesivir received an emergency use authorization, or EUA, from the Food and Drug Administration, which it received in May following the release of data from a randomized, placebo-controlled study sponsored by the National Institute of Allergy and Infectious Diseases. The data showed that patients who received remdesivir recovered four days faster – within 11 days – than those in the placebo group.

Most recently, data from a Phase III study run by Gilead showed that a greater percentage of patients with moderate Covid-19 pneumonia who received the drug over five days showed a benefit on a scale of clinical improvement than did those who received the drug for 10 days.

But because the current version of remdesivir is administered intravenously, studies to date have been limited to patients who are hospitalized. The inhaled formulation of the drug is meant to enable studies of it in patients who are at earlier stages of Covid-19. In addition. O’Day wrote that Gilead plans to study the intravenous formulation in outpatient settings, such as infusion centers and nursing homes.

Several other companies are also developing drugs for Covid-19, including those that treat the extreme immune system reactions associated with severe symptoms, as well as direct-acting antivirals. Earlier this month, Regeneron Pharmaceuticals started clinical development of a cocktail treatment of two monoclonal antibodies developed specifically for the SARS-CoV-2 virus, while PTC Therapeutics plans to run a clinical trial of a cancer drug that it hopes can tackle both the virus and the inflammation associated with Covid-19.

Photo: Ulrich Perrey, Pool/AFP, Getty Images

Shares0
Shares0