On Thursday, Drug Innovation Ventures at Emory (DRIVE) submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for their experimental COVID-19 treatment, EIDD-2801.
EIDD-2801 is an antiviral compound that directly attacks coronaviruses in the lungs. The compound, a nucleoside analogue, deceives the virus into attaching and injecting its genetic information into a false host.
CEO of DRIVE, director of the Emory Institute for Drug Development (EIDD) and Professor of Pharmacology George Painter (72C, 77G) and his team have been working on the oral therapy for over five years and in the past month partnered with biotechnology company Ridgeback Biotherapeutics. The original purpose behind the treatment was to combat influenza, but Painter said the medicine can also be used to treat COVID-19 and other coronavirus strains. The novel coronavirus outbreak has brought the opportunity to find a partner and accelerate FDA approval to DRIVE’s process.
“[Ridgeback is] well suited to us because they deal with emerging infectious disease,” Painter said. “At a certain point, the structure of a university really isn’t the optimal place to develop a drug. There are various procedures for the university that are not very compatible with moving quickly.”
Ridgeback Biotherapeutics have an exclusive license of the intellectual property over the compound. If approved by the FDA, Ridgeback can develop, commercialize and sell EIDD-2801.
“DRIVE and Emory get milestone payments and royalties,” Painter said. “A lot of that will come back to DRIVE and be put right back into its effort to identify and develop critical medicines for unmet medical needs.”
Over the past three years, Painter and his team have gathered an enormous amount of data, which they have been working on compiling in the past few months.
The IND application is titled “The Use of EIDD-2801 for the Treatment of Influenza” and consists of hundreds of hyperlinked research reports about the compound.
After an IND application is submitted, the FDA must respond within 30 days. However, Painter predicts that the FDA will respond sooner because of COVID-19’s exigent danger. Although there is no official communication from FDA stating an accelerated approval process, Painter assured that he and his team have been in frequent contact with the FDA about their response.
Painter hopes that in three to four weeks, the treatment will be tested on patients in the form of clinical trials, off-label medicines and trial basis. EEID-2801 will first be tested on healthy volunteers and later on COVID-19 patients if initial testing succeeds.
Amid the University’s closure, Painter’s lab is only allowed to operate with essential personnel. However, Painter’s team is carrying out critical maintenance on lab equipment.
Painter emphasized the imperative group effort of this process, stating that, “a lot of people put in long hours, many more than they had to, in order to get this out the door.”
“A lot of credit to a lot of people,” Painter said. “Let’s just cross our fingers and hope it works.”