Early in August, TrialSite highlighted that consumer advocacy organizations such as Public Citizen continue to pester federal research agencies to pressure Gilead to develop a similar drug to remdesivir known as GS-441524. Gilead’s remdesivir patent lasts longer, or at least so says the cynics, and hence the focus of the shrewd biotech company would be the money maker. The only drug with emergency use authorization (recently convalescent plasma also in that category), Gilead stands ready to make a windfall. A smart business, Gilead knows it must continuously satisfy shareholders. On the other hand, they possess GS-441524, which possibly shows even more antiviral promise. Well, looks like consumer protection groups such as Public Citizen continue to remain important. The National Institutes of Health now agrees with their (Public Citizen) position that GS-441524 should be investigated as an antiviral against COVID-19.
It appears Dr. Francis Collins, Dr. Anthony Fauci and Dr. Christopher Austin and the scientists at the National Institutes of Health concur with Public Citizen’s position, and hence the government research agency will proceed with preclinical studies of GS-441524.
In a response letter, Dr. Christopher Austin, director of the NIH’s National Center for Advancing Translational Sciences, wrote on August 22 that “Scientists in our Division of Preclinical Innovation have reviewed the literature and agree that merits further exploration.” The letter conveyed that the government research group would conduct rapid preclinical studies of the drug.
Public Citizen Praises the NIH
Public Citizen “applauded the government response and commitment as Michael Abrams, health researcher for the non-profit advocacy group communicated a thank you and suggested any movement was “long overdue.” Representing Public Citizen, Abrams commented “We hope that Gilead will respond similarly and commit to working collaboratively with the NIH to study the potential of GS-441524, even if it means the company may reap lower profits than expected from the marketing of remdesivir.”
Public Citizen is pushing Gilead toward a tough decision: Gilead shareholders expect big returns, and growth and remdesivir sales are undoubtedly factored into that equation.
What is GS-441524?
This antiviral drug, developed by Gilead, is described as the main plasma metabolite of the antiviral product remdesivir, which has a half-life of about 24 hours in humans. As defined in Wikipedia, the nucleoside of GS-441524 is phosphorylated. By nucleoside kinases, and then phosphorylated again by nucleoside-diphosphate kinase (NDK) to the active nucleotide triphosphate form.
Known as the “black-market drug from China,” the drug is based on research from University of California, Davis, according to an article The Atlantic. Both Remdesivir and GS-441524 were tested against feline infectious peritonitis (FIP), a lethal coronavirus disease impacting domestic cats, and widely used despite no U.S. Food and Drug Administration (FDA) approval due to Gilead’s actual refusal to license the drug for veterinary use. At least one study has revealed that GS-441524 is comparable or perhaps even more powerful than remdesivir against SARS-CoV-2 in a cell culture.
In fact, a pair of researchers out of MD Anderson posit that GS-441524 is possibly superior to remdesivir for the treatment of COVID-19.