On June 22nd, Gilead Sciences released an open letter from Daniel O’Day, chairman and chief executive, through its official WeChat account, saying that Gilead Sciences had obtained approval from the U.S. Food and Drug Administration and would begin trials of Redsewere inhaled formulations. Health volunteers will be screened for a phase of the trial this week and hope to begin their study of patients with new coronavirus pneumonia in August.
“If the trial is successful, it will represent important progress,” Gilead Sciences said, adding that inhaled formulations will be administered through nebulizers, which will make it possible for patients to take easier medications in the early stages of the disease and outside the hospital.
Redsewe’s antiviral drugs for Gilead Sciencehave have been clinically available in several countries. So far, Redsewe’s randomized controlled trials have been evaluating its safety and efficacy in hospitalized patients, Gilead Science sylls said. In the Study of the National Institute of Allergy and Infectious Diseases, Redsewe reduced recovery time by an average of four days, and in the SIMPLE study of patients with moderate new coronavirus pneumonia (patients hospitalized but not requiring oxygen absorption), patients who received the 5-day course of Redsewe received better clinical outcomes than those receiving standard treatment.
At the end of April, Redsewe’s clinical trials in China were released showing that 237 patients were randomly assigned to the treatment group between February 6 and March 12. Preliminary studies showed no clinical significant improvement in Redsewe’s treatment of the severe case of new crown pneumonia.