Emory researchers who have discovered a potential treatment for the novel coronavirus (COVID-19) plan to meet with officials from the Food and Drug Administration (FDA) to discuss the future of their experimental drug to combat COVID-19 on Thursday, according to Emory lead researcher and Professor of Pharmacology George Painter (72C, 77G).
Painter said that he and his team have submitted requests for general information regarding the beginning the process of approval to the FDA and will receive written notice of the information from the FDA on Wednesday. On Thursday, the FDA and Painter’s team will discuss the potential path to approve the drug for clinical trials.
The research project is a collaboration between members of the Emory Institute for Drug Development and departments from the Vanderbilt University School of Medicine (Tenn.) and the University of North Carolina at Chapel Hill, the Wheel previously reported. Painter and his team started researching coronaviruses in 2013.
Painter said that following feedback from the FDA, his team will next submit an Investigational New Drug application, which would commence the next stage of research and development of the treatment. Painter added that if the spread of COVID-19 continues to progress rapidly, the FDA approval process could be expedited.
“If requirements for therapeutics become more acute, then it’s likely that the government will work to help speed up the process to get experimental drugs to people to help,” Painter said.
Painter also acknowledged that there are other experimental drugs currently being evaluated to treat COVID-19. They too are repurposed drugs developed from past outbreaks.
During the Ebola outbreak in the Congo region, an experimental drug called remdesiver, created by biomedical company Gilead Sciences Inc., went through a similar FDA process but ultimately proved ineffective at treating Ebola. The drug is now repurposed to potentially treat COVID-19. However, the drug’s timeline is further ahead than Emory’s because of its success with the FDA’s previous approval in 2014.
Remdesiver is only available in intravenous form, which Painter discredited, stating that it is essential to have a self-administered pill version to allow for more accessibility when treating these deadly diseases.
When asked about the future of his drug, Painter seemed optimistic about its ability to help people even though it is early in the FDA approval process. Painter also distinguishes Emory’s potential treatment because it actively attacks the virus in the lung tissue, unlike many other drugs.
“We’ve been working on the drug for a long time, for flu, [severe acute respiratory syndrome] and [Middle East respiratory syndrome],” Painter said. “So when the new coronavirus came, all the work that had been previously done could be applied. So I feel well-prepared, and hopefully we’ll get the [FDA] go-ahead, and we’ll move as quickly as we can.”
Painter also envisioned how the drug could be useful in treating viruses similar to COVID-19 after its eradication.
“[If it gets approved], then the drug would be there if that happened,” Painter said. “So that’s the new idea, find drugs that treat multiple viruses and have the potential to treat the emerging virus. Then you’re ready, and you don’t have all this process to go through.”
Although the process with the FDA usually takes many months, he and his team hope the pill will be out this spring.
On Feb. 25, the Centers for Disease Control and Prevention (CDC) updated their Coronavirus Disease 2019 (COVID-19) Situation Summary, warning Americans to prepare for a coronavirus outbreak.
“More cases are likely to be identified in the coming days, including more cases in the United States. It’s also likely that person-to-person spread will continue to occur, including in the United States,” the CDC website reads as of Tuesday evening. “Widespread transmission of COVID-19 in the United States would translate into large numbers of people needing medical care at the same time.”
The Wheel spoke with Epidemiology Professor at the Rollins School of Public Health Benjamin Lopman and Infectious Diseases Associate Professor at the Emory School of Medicine Aneesh Mehta (99C) about their reactions to the update.
“It’s looking increasingly likely that there will be a pandemic,” Lopman said. “There’s going to be local outbreaks across the world. Whether this will happen in our community is unknown.”
Both professors stressed that the most effective way to prevent any illness, including COVID-19, is for individuals to use “healthy hand hygiene” — frequent handwashing and continued cautiousness of contamination.
Lopman and Mehta both were pessimistic about relying on a vaccine to solve this epidemic, citing the slow process of testing and research necessary to create an effective vaccine.
Ayushi Agarwal contributed reporting.