Date: Oct 13, 2020 Author: Paul J. Gough Source: Pittsburgh Business Times (
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CytoAgents, a Pittsburgh-based pharmaceutical company whose drug candidate battles a deadly side effect of respiratory illnesses like Covid-19, has reached the phase-one clinical trial stage.
The drug candidate, GP1681, is an existing small-molecule drug that CytoAgents had before the pandemic been investigating for use in treating cytokine storm, an immune response that causes inflammation and respiratory distress for people with severe influenza. The same response happens in some Covid-19 patients and CytoAgents wants to know if it can be used in people with severe Covid-19.
The phase-one clinical trial won't treat Covid-19 or any other respiratory patients. The healthy patient trial, as it's called, will instead test the safety of GP1681. The phase-one trial is underway in Australia under the auspices of CytoAgents' partners, CMax Clinical Research and Novotech, which is based in Australia.
The trial, in 24 patients, should be complete by the end of the year with results completed by early 2021. CytoAgents hopes to start the phase-two clinical trial, among people with Covid-19 who are at risk of cytokine storm, soon after. It expects to raise a Series A level of funding in 2021 to help pay for the clinical trials. The phase-one trial is smaller than normal because there is already safety data in hand due to earlier work pre-Covid with the drug candidate, said CytoAgents CEO Teresa Whalen.
"We've been able to expedite a smaller trial, which is why it will end so quickly and we can go right into Phase 2," Whalen said in an interview Tuesday afternoon.
Time is of the essence in battle against Covid-19, of which immunotherapy treatments like CytoAgent's will be a part. So will a vaccine and other treatments and therapies. CytoAgents' development has been fueled by big recent grants, a $1.6 million grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, as well as $250,000 from the Richard King Mellon Foundation from its pandemic initiative.
Whalen said CytoAgents has its eye on the future beyond Covid-19 as well.
"Our mission is to develop proof of concept in Covid-19 and then expand our pipeline to other sources," she said. "This is a long-lasting treatment for many causes of cytokine storm. Future respiratory epidemics will also cause cytokine."
And, through work with Tulane University, CytoAgents is also looking at other ways that its drug candidate, if successful, can treat infectious and noninfectious causes of cytokine storm. One would be vaping-induced lung injury, Whalen said.
"Covid-19 is the short term and then the long term is to be a lasting treatment for any cause of cytokine storm, and there are many," she said.
