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September 4, 2020
Bioscience
FDA green-lights trial for Yale researcher’s potential COVID-19 treatment
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By Natalie Missakian
Federal regulators have given Yale University researchers the green light to begin human testing on a potential treatment for a deadly respiratory complication of COVID-19.
Yale’s Office of Cooperative Research (OCR) said it has received a “safe to proceed'' letter from the U.S. Food & Drug Administration, paving the way for a clinical trial on a drug being developed by Yale pulmonologist Naftali Kaminski, MD.
Kaminski and his team had been developing the drug, AN19, also known as Sobetirome, to treat lung fibrosis, but discovered it could also be effective in preventing and treating Acute Respiratory Distress Syndrome (ARDS).
The potentially fatal condition is a complication commonly found in severe cases of COVID-19.
The drug has been shown in mice to improve lung injury and inflammation caused by ARDS, according to Yale. It has also been shown to reverse lung fibrosis, which occurs when lung tissue becomes damaged and scarred.
The trial was designed by Kaminski, chief of pulmonary, critical care and sleep medicine at Yale, along with Argyrios Tzouvelekis, MD, of the University of Patras, Greece.
Yale pulmonologist Naftali Kaminski, MD.
The Phase 2, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of AN19 in preventing and treating ARDS in hospitalized patients with moderate-to-severe COVID-19.
It will examine whether the drug reduces the need for mechanical ventilation or lowers the death rate for patients. The drug, a thyroid hormone agonist, works by protecting the cells that make up the lining of the lung, Kaminski said.
He credited Yale for helping to move the drug quickly through the regulatory process.
“To be honest, I had my doubts whether we could proceed so rapidly during a pandemic,” Kaminski said in a statement. “In addition to designing the trial and obtaining FDA approval, we had to certify and formulate AN19 to ensure it was ready for distribution.
“These tremendous tasks were achieved in record time through the leadership and unlimited efforts of the OCR team, in collaboration with Yale’s Center for Clinical Investigations and external experts and collaborators,” he added.
Yale’s OCR helps facilitate the commercialization of scientific research originating at the university. A spokeswoman for the office said plans for the multi-site trial are in the process of being finalized.
Contact Natalie Missakian at news@newhavenbiz.com
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