The company behind the only drug approved by the U.S. Food and Drug Administration for treatment of COVID-19 announced Monday plans to begin clinical trials of an inhaled version of the drug, which, if proven beneficial, could make it easier to administer and treat people earlier.
In an open letter posted to Gilead Sciences website Monday, the company’s chairman and CEO, Daniel O’Day, wrote that they hope to begin clinical trials in August.
“After receiving the green light from the FDA to move forward, Gilead is about to start trials of an inhaled version of Remdesivir. We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 in August,” O’Day said. “If the trials are successful, this could represent important progress.”
Remdesivir is currently given to patients intravenously through daily infusions in the hospital. Early results of a large clinical trial of the drug showed that those who received remdesivir, rather than a placebo, recovered 31 percent faster.
“An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of disease. That could have significant implications in helping to stem the tide of the pandemic,” O’Day wrote in his letter.
Remdesivir doesn’t work as well on COVID-19 patients who are experiencing more severe symptoms, and for those who require ventilation, however.
There is also currently a limited supply of the drug, Alabama physicians have said in recent press briefings.
“Although the total supply of remdesivir is limited, we are grateful that hospitalized COVID-19 patients with severe disease in Alabama can receive this potentially lifesaving medication,” Alabama State Health Officer Dr. Scott Harris said in a statement in May. “Because the quantity is limited, the physician members of the Governor’s Coronavirus (COVID-19) Task Force determined a formula to distribute the allotment equitably among the state’s hospitals.”
Dr. Robert Kadlec, the assistant secretary for preparedness and response at the U.S. Department of Health and Human Services, told CNN that the U.S. government’s supply of Remdesivir will run out at the end of June.
“Right now, we’re waiting to hear from Gilead what is their expected delivery availability of the drug as we go from June to July,” Kadlec told CNN. “We’re kind of not in negotiations, but in discussions with Gilead as they project what the availability of their product will be.”