Athersys, Inc. said Monday it has received approval from the U.S. Food and Drug Administration to start a Phase 2/3 trial to assess the safety and efficacy of its MultiStem therapy in patients with moderate to severe acute respiratory distress syndrome or ARDS induced by COVID-19.
According to the World Health Organization as well as other recent clinical and epidemiological data, ARDS is the leading cause of death among COVID-19 infected patients. There are no FDA-approved medicines for the treatment of ARDS.
Athersys plans to open the first clinical sites for recruitment of the MACOVIA study this quarter.
The primary efficacy endpoint of the MACOVIA study will be number of ventilator-free days through day 28 as compared to placebo.
The secondary objectives of this study are to evaluate pulmonary function, all-cause mortality, tolerability and quality of life or QoL among survivors.
The study will enroll about 400 patients and will be conducted at leading pulmonary critical care centers throughout the U.S.
Athersys said it recently completed a Phase 1/2 study evaluating administration of MultiStem to patients with ARDS.
The data from the study met its primary endpoint of tolerability and patients were evaluated for 28 days on key clinical parameters as well as improvement in pulmonary function, Athersys noted.
Patients who received MultiStem experienced less mortality, more ventilator-free days, and more intensive care unit or ICU-free days during the 28-day clinical evaluation period than the patients who received placebo.
Based on data from the study, the FDA recently granted Fast Track designation to the program.
Athersys also said it is in talks with the Biomedical Advanced Research and Development Authority or BARDA to expedite the advancement of MultiStem to treat patients with ARDS resulting from the COVID-19 epidemic and other potential pandemic outbreaks.
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