On May 5, 2020,  Athersys announced that the first patients have been enrolled in Athersys’ pivotal Phase 2/3 study entitled, MultiStem^® Administration for COVID-19 Induced Acute Respiratory Distress Syndrome (MACOVIA). The patients were enrolled at University Hospital’s Cleveland Medical Center (UH Cleveland), a leading pulmonary critical care center and a nationally ranked hospital. Medpace, a leading contract research organization (CRO) based in Cincinnati, Ohio, is serving as the CRO for this study.

With the continued spread of COVID-19 and the resulting cases of severe respiratory distress among those patients that become seriously ill, there is an immediate need for therapies. The Company’s program evaluating administration of MultiStem for the treatment of ARDS was recently granted Fast Track designation by the FDA based on the promising Phase 1/2 data from its previously completed MUST-ARDS trial. Currently there are no FDA-approved medicines for the treatment of ARDS.

This study is designed to enroll approximately 400 subjects. The first patients were enrolled into the first cohort of the study, which is an open-label, single active treatment arm to evaluate the safety of MultiStem administered at two dose levels to study subjects with moderate to severe ARDS associated with COVID-19. If the treatment is well tolerated in this first cohort, the study is designed to further evaluate MultiStem efficacy, safety and tolerability in this patient population using a robustly powered, double-blind, randomized and placebo-controlled trial protocol.

The primary efficacy endpoint for the MACOVIA study will compare the number of ventilator-free days through day 28 among MultiStem and placebo treatment groups. Secondary objectives of the study are to evaluate 60-day all-cause mortality, time in the intensive care unit, pulmonary function, tolerability and quality of life (QoL) among survivors through one-year of follow-up.

MultiStem cell therapy’s potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. Since MultiStem is not virus- or pathogen-specific, it may have the potential to treat ARDS that develops from a variety of causes, including COVID-19, as well as other pathogen-induced or non-infectious causes of severe lung inflammation leading to ARDS. The Company is in discussions with the Biomedical Advanced Research and Development Authority (BARDA) to expedite the advancement of MultiStem to treat patients with ARDS resulting from the COVID-19 epidemic and other potential pandemic outbreaks.