The approval falls under the US Food and Drug Administration’s expanded access protocol (EAP) treatment program in the US, the Toronto-based company said in a statement.
Bucillamine, an approved drug for rheumatoid arthritis, is being explored as a possible treatment for infected patients suffering from inflammation in their lungs. The EAP for compassionate use is a multi-centre, open label study of Bucillamine in hospitalized patients with severe COVID-19, Revive told shareholders. The program will be a complement to Revive’s ongoing Phase 3 COVID-19 study in the US.
READ: Revive Therapeutics wins Institutional Review Board approval for its Phase 3 trial protocol to evaluate Bucillamine in COVID-19 patients
An IRB operates under US regulations and is an FDA-registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects.
As part of the EAP, physicians may access Bucillamine under Revive’s existing Investigational New Drug application for COVID-19. Expanded access is a potential method for critical patients to access an investigational medical product outside of clinical trials.
“With the IRB approval of the expanded access protocol by Advarra, a premier IRB services company in North America, hospitalized patients with severe COVID-19 may access Bucillamine under the FDA compassionate use program under medical supervision by their physician,” said Michael Frank, Revive’s CEO in a statement. “The EAP serves as an option for patients that are not eligible for inclusion criteria in our Phase 3 clinical study in COVID-19 and the resulting data from the EAP will be valuable in supporting our clinical development of Bucillamine.”
Revive expects to have patients enrolled in the United States this month.
Shares of Revive jumped 10.2% in Wednesday morning trading at C$0.27.
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