Gilead Sciences will begin human trials for an inhaled version of its antiviral drug remdesivir in August, the biotech company said Monday.Remdesivir, which was granted an emergency use authorization (EUA) from the Food and Drug Administration to treat patients hospitalized with Covid-19, is administered intravenously. The company told investors in April that it was looking to develop easier-to-administer versions of the drug, including an inhaled version. The drug can’t be administered in pill form because its chemical makeup would impact the liver, the company noted.
Gilead said it will administer the drug through a nebulizer, a delivery device that can turn liquid medicines into mist.An inhaled version “could potentially allow for easier administration outside the hospital, at earlier stages of disease,” Gilead Chairman and CEO Daniel O’Day said in an open letter Monday. “That could have significant implications in helping to stem the tide of the pandemic.”
WHO Says Sunday’s Coronavirus Cases the Highest Yet in a Single Day
The world recorded more than 183,000 new coronavirus cases on Sunday, the most in a single day since the outbreak started, World Health Organization chief Tedros Adhanom Ghebreyesus said on Monday.He said the next big challenge was to increase production and distribution of dexamethasone, the first drug shown to lower the risk of death in severely ill COVID-19 patients.
Global infections surpassed 9 million on Monday, as Brazil and India grappled with a surge in cases and the United States, China and other hard-hit countries reported new outbreaks, according to a Reuters tally.
Institute Halts COVID-19 Clinical Trial for Hydroxychloroquine Due to Low Enrollment
The National Institute of Allergy and Infectious Diseases has shut down a clinical trial to see if a combination of hydroxychloroquine and azithromycin can prevent hospitalization and death due to COVID-19.The trial, launched last month, aimed to enroll 2,000 outpatient participants nationwide — including subjects recruited through the University of Washington School of Medicine. But on Saturday NIAID, which is part of the National Institutes of Health, said that only 20 participants had been enrolled, and that such a rate was deemed “inadequate for the trial to meet its objectives in a timely matter.” Another NIH clinical trial was halted as well.
Telescoping testing timelines and approvals may expose all of us to unnecessary dangers related to the vaccine. While preclinical trials to evaluate the potential safety and efficacy of vaccine candidates are likely to include tens of thousands of patients, it is still unclear whether that number will be large enough and a trial will last long enough to evaluate safety for a drug that would be administered to so many. The US alone plans to vaccinate hundreds of millions of people with the first successful candidate. One serious adverse event per thousand of a vaccine given to 100 million people means harm to 100,000 otherwise healthy people.