All About EIDD-2801: A Little Known but Very Promising Covid-19 Drug
The world is waiting for an antiviral drug that can effectively treat Covid-19. Ideally, it would come in pill form so that it can be easily distributed across the globe and given at the first sign of symptoms. It should be safe in humans and pass the U.S. Food and Drug Administration approval process with flying colors. Millions of doses should be produced ahead of time to prepare for the day it is approved for use. Ideally, it would be developed by a team of antiviral drug experts tasked by the U.S. government to address pandemics. Sound too good to be true? Surprisingly, it isn’t. This drug exists and is called EIDD-2801. So why haven’t you heard about it?
The first time I came across it, I was lying in bed on a Sunday morning scrolling through LinkedIn. I was exhausted. I’d been traveling weekly from Washington, D.C. to New York City as part of a three-month fellowship for NBC News, and a new coronavirus epidemic had emerged in China. The World Health Organization had just named the disease Covid-19 but hadn’t yet declared a pandemic. While I would have preferred to sleep in, the news cycle ensured that I woke up every morning at 6 a.m. to check email. Medical history was being made, and I was working with some of the best journalists in the business.
After responding to a few messages, I began scrolling through social media. I stumbled across an article about a GoFundMe page launched by Emory University researchers. They had a drug for Covid-19 for which they were desperately seeking FDA approval. I read on. The drug, EIDD-2801, works by providing faulty building blocks to the machinery that the virus uses to multiply. My interest was piqued. According to another Emory article, the drug is effective in the lab against all coronaviruses, including SARS, MERS, and SARS-CoV-2, and it stops other RNA viruses that cause severe respiratory infections, like influenza virus and respiratory syncytial virus (RSV).
Holy cow! I immediately recognized the significance. If this drug worked against Covid-19, influenza, and RSV, doctors could prescribe it for an unknown flu-like illness before knowing the results of a Covid-19 test. At the time, the new coronavirus test was only available through the Centers for Disease Control and Prevention and could take days to be approved and run. With its broad-spectrum activity, EIDD-2801 would likely tackle the respiratory virus responsible for symptoms while doctors waited on a test result.
The drug, EIDD-2801, works by providing faulty building blocks to the machinery that the virus uses to multiply.
The fact that EIDD-2801 is an oral medication was even more exciting. Remdesivir, the only other antiviral medication available for Covid-19, is administered intravenously. A patient can only receive it if they are sick enough to be hospitalized. The beauty of an oral drug is that it can be given early, before hospitalization, while symptoms are still mild.
This last point was vital. Antivirals often need to be given early to be effective. For example, the influenza drug Tamiflu has to be initiated within the first 72 hours of symptoms. Antivirals for herpes, like Valtrex and Famvir, need to be started at the early signs of a flare-up to make a difference. A viral illness is often too advanced for an antiviral medication to work if too much time has passed. Plus, a safe and potent drug in oral form could be distributed widely to the public and to areas of the world where health care is scarce. I knew the magnitude of what was at stake. I needed to find out more.
“We absolutely need the GoFundMe money in order to pay the bill to get the coronavirus drug out there. In the absence of that money, we are operating at a deficit,” explained George Painter, PhD, lead researcher and director of the Emory Institute for Drug Development (EIDD), when I spoke with him. Painter is also the CEO of Drug Innovation Ventures at Emory (DRIVE).
DRIVE is a nonprofit biotechnology company owned by Emory University. They started the GoFundMe campaign to raise $5 million to start FDA clinical trials. The researchers initially developed the drug with federal funding for influenza, but they weren’t allowed to use that money for any other purpose. They were well-positioned to shift the research focus to the coronavirus, said Painter, but they needed to hire biotechnology experts and consultants to prepare the approval documents and move the process forward.
Submitting an application to the FDA for clinical trials is a drawn-out process. It can take years and a lot of costly expertise and manpower, said Painter. The team had already cut that time in half, said Painter, and they were hoping to apply by the end of April.
Painter felt confident that EIDD-2801 would be safe and work against the new coronavirus, and even future coronaviruses. Studies done in collaboration with the University of North Carolina at Chapel Hill and Vanderbilt University Medical Center had shown its remarkable effect on RNA viruses and its safety in lab animals. The drug absorbed well enough to have high concentrations in the lungs, brain, and other critical areas when given orally to study animals, said Painter.
Also, viruses don’t appear to develop resistance to it. “After repeated exposure to the drug, a virus doesn’t emerge that is insensitive to the drug,” said Painter.
I pitched the story idea to my editors, but it was still too early. News media is reluctant to cover drugs in the preclinical research phase for a good reason. Researchers must prove that a drug is safe, well-absorbed, effective, and well-tolerated in humans. Clinical trials can take many years. In extenuating circumstances, the FDA can issue an emergency use authorization to speed up the process. Still, researchers must at least prove human safety. The researchers for EIDD-2801 had yet to show any of those things.
The FDA can’t review the preliminary data or do anything about a promising new drug until they receive an application, said Michael Stanfield Jr, regulatory information specialist at the FDA Division of Antiviral Products. Once it is submitted, the FDA is required to respond to an application within 30 days. In light of the current pandemic, the FDA has encouraged submissions and expedited the review process to allow clinical trials to start as soon as possible for potential Covid-19 drugs.
I had faith that EIDD-2801 would be a valuable Covid-19 drug if given a chance. Painter had developed pharmaceuticals for the private sector for decades before returning to his alma mater to do nonprofit work. At Emory, he helped develop HIV and Hepatitis C drugs that are now used worldwide, including the likes of Truvada. DRIVE was established in response to the 2006 Pandemic and All-Hazards Preparedness Act (PAHPA). The organization finds and develops new drugs to fight emerging infectious diseases without the financial motivations of for-profit pharmaceutical companies, said Painter. “Any money that’s made is put right back into the efforts that sustain it,” he said.
Painter is also working with legends like Dennis Liotta, PhD, professor of Chemistry at Emory University and an expert in drug development, and Mark Denison, MD, professor of microbiology and immunology at Vanderbilt University School of Medicine and an expert on coronaviruses. As a graduate of both schools, I’d attended classes taught by both of these professors. They are brilliant. Much like Painter, these scientists have forgone the financial benefits of working in the private sector for the sake of public health and education.
By June, the drug passed phase one clinical trials (safety in humans), and Ridgeback launched phase two trials to prove its efficacy in hospitalized and nonhospitalized patients.
I tried to gain traction on the story by looking for an impartial expert to confirm my intuitions, but I was challenged to find an expert who wasn’t already involved with some stage of the research or development of the drug. I ultimately spoke with Stanley Perlman, MD, professor of microbiology and immunology at the University of Iowa. He’s a pediatric infectious disease specialist who has been working with coronaviruses for 38 years. He knew about the drug, though he hadn’t been involved in its development. Denison had worked in his lab decades prior. After speaking to me briefly, he called Denison to learn a little more about the research and then called me back.
“Right now, I think it’s better than most of the other drugs that are being tested in Covid-19 patients,” Perlman said. “The virus doesn’t readily develop resistance, and there is reasonable evidence to suggest this will work against the coronavirus as an oral drug, which is really what we need. If you have a drug that you can relatively easily give to anybody who has mild illness, we may be able to stop the infection in those patients who would otherwise develop severe illness.”
Sadly, my fellowship with NBC was coming to an end and the research still hadn’t progressed enough to make the story ready for prime time. I was heartbroken that I wouldn’t be able to break the news and a little frustrated that, somehow, azithromycin and hydroxychloroquine made it into mainstream media with little evidence to support their use. Meanwhile, a truly promising drug was left on the back burner and might not get the funding it needs.
By March, DRIVE had partnered with Ridgeback Biotherapeutics, a privately held biotechnology company in Miami. The details of the deal weren’t public, but Ridgeback acquired exclusive licensing rights to the drug in exchange for bringing it to clinical trials. By late April, further research was published showing the drug’s efficacy against coronaviruses in human lung cells, in the lungs of infected mice, and on viruses that had developed resistance to remdesivir. In late May, Ridgeback partnered with Merck, the pharmaceutical giant, who now has exclusive rights to develop and distribute EIDD-2801 worldwide. By June, the drug passed phase one clinical trials (safety in humans), and Ridgeback launched phase two trials to prove its efficacy in hospitalized and nonhospitalized patients. The #EndPandemicsNow GoFundMe campaign, by the way, never made it past $38,193.
The Washington Post recently published an excellent article about the ethics of these pharmaceutical company deals, which I won’t try to reproduce. According to the article, the folks at Emory are simply happy to have discovered a drug that will hopefully benefit society. Personally, I am glad the drug development and trials are progressing. Though I admit to feeling a bit chagrined that the drug went from the hands of a nonprofit whose fundamental mission is to end pandemics to those of a pharmaceutical giant that answers to shareholders. With the cost of remdesivir currently in the thousands, who knows what the price of EIDD-2801 will ultimately be.