Athersys started enrollment of patients testing MultiStem cell therapy in a rapid advancement of clinical program for the treatment of ARDS based on prior clinical data reflecting favorable tolerability data and meaningful benefits on mortality, ventilator-free days and ICU-days
CLEVELAND–(BUSINESS WIRE)–$ATHX #ARDS–Athersys, Inc. (NASDAQ: ATHX) announced today 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.
“New treatment options are needed for patients with severe COVID-19 induced ARDS. However, it is important that potential therapies are scientifically evaluated as part of a clinical trial,” commented Site Principal Investigator, Dr. Frank Jacono, MD, Associate Professor of Medicine and a Pulmonary and Critical Care Medicine Physician at University Hospitals Cleveland and the Cleveland VA Medical Center. “We are pleased to partner with Athersys to advance this important clinical study to evaluate treatment of critically ill patients with COVID-19-induced ARDS,” concluded Dr. Jacono.
Other MACOVIA clinical investigators at UH Cleveland include Dr. Rana Hejal, MD, Pulmonary and Critical Care Medicine Specialist and Medical Intensive Care Unit (MICU) Director, Dr. Catalina V. Teba, MD and Dr. Olivia Giddings, MD, PhD, both Pulmonary and Critical Care Medicine Specialists.
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.
About COVID-19
COVID-19 is the infectious disease caused by the most recently discovered human coronavirus, SARS-CoV-2. This new disease was unknown before the outbreak was first discovered in Wuhan, China, in December 2019. Older people and those with underlying medical problems such as high blood pressure, heart problems or diabetes, are more likely to develop serious illness, but even young, previously healthy people can suffer severe disease and complications such as ARDS. Data are still emerging, but recently published case series suggest mortality rates among COVID-19 patients who develop ARDS may be 50% to 70%, or perhaps even higher in some environments.