ST. LOUIS — A treatment for COVID-19 patients that was developed in St. Louis will soon begin an investigator-initiated human trial.
The treatment was developed by the team at Confluence Discovery Technologies as part of Aclaris Therapeutics. The team resides at the building of startup support organization BioSTL and was purchased by Aclaris in 2017.
Aclaris announced Wednesday that the FDA approved its drug, ATI-450, for a trial with 36 hospitalized patients with COVID-19. The FDA will provide funding and clinical drug supply to the University of Kansas Medical Center, the trial's sponsor.
The trial will study the drug's ability to treat Cytokine Release Syndome (CRS), a condition that leads to the release of inflammatory cytokines. It precedes acute respiratory distress syndrome and is associated with significant morbidity and mortality of coronavirus patients, according to trial co-investigator Dr. Gregory Gan.
“By mitigating CRS, important clinical outcomes such as oxygenation in patients with COVID-19 would be improved which could result in the reduced need for ventilation in patients in the intensive care setting," Gan said.
The trial will measure the proportion of patients who are free of respiratory failure by day 14. In phase 1 clinical trials with healthy volunteers, it has already shown the ability to regulate inflammatory cytokines associated with CRS, Gan said.
Aclaris Chief Medical Officer Dr. David Gordon said the ATI-450 stands out from many drugs being evaluated to treat CRS because it targets multiple cytokines instead of one.
“We believe inhibiting multiple cytokines has the potential to achieve clinical benefits in patients with CRS, and this study will explore if ATI-450 is an effective approach in these patients," Gordon said. "Thanks to KUMC, who are sponsoring this trial, we are able to evaluate ATI-450 as a potential treatment for COVID-19 at this critical time without impacting our ongoing clinical development programs. If successful, we hope to further explore the role that ATI-450 may have in helping patients with COVID-19 and addressing the healthcare challenges of the pandemic.”
"The team is very excited about the potential for this drug and have been working with the FDA for the past three months to get approval to begin in-patient studies," said BioSTL spokesperson Maggie Crane.
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