Athersys and UH announce activation of first clinical site for MACOVIA study, a pivotal Phase 2/3 study evaluating Multistem® cell therapy for COVID-19 induced ARDS

University Hospitals Cleveland Medical Center, a nationally ranked hospital, is ready to start screening patients

Athersys, Inc. (NASDAQ: ATHX) and University Hospitals Cleveland Medical Center (UH Cleveland) announced today that UH Cleveland is now open as the first clinical site for the MACOVIA (MultiStem Administration for COVID-19 Induced Acute Respiratory Distress Syndrome) trial.

On April 13, 2020, Athersys announced authorization from the U.S. Food and Drug Administration (FDA) to begin the MACOVIA study and began the process of clinical site initiation. UH Cleveland has completed trial start-up activities enabling commencement of patient screening and enrollment in this important randomized, double-blind, placebo-controlled study.

Frank Jacono, MD, Pulmonary and Critical Care Medicine Physician at UH Cleveland and Cleveland VA Medical Center; and Associate Professor of Medicine Case Western Reserve University School of Medicine, will serve as principal investigator. UH Cleveland is now screening COVID-19 induced ARDS patients for inclusion in the trial.

Acute respiratory distress syndrome (ARDS) is the leading cause of death among COVID-19 infected patients, according to the World Health Organization and other recent clinical and epidemiological data. With the spread of COVID-19, there is an immediate need for therapies for the treatment of ARDS. The MACOVIA trial aims to confirm the safety and efficacy of MultiStem therapy as a treatment for patients with moderate to severe ARDS due to COVID-19.

UH Cleveland is a leading pulmonary critical care center in the United States and also participated in Athersys’ completed Phase 1/2 MUST-ARDS study. The data from the MUST-ARDS study met its primary endpoint of tolerability, and study subjects receiving MultiStem experienced less mortality, more ventilator-free days and more intensive care unit (ICU)-free days during the 28-day clinical evaluation period than the subjects who received placebo. Based on this promising data, the FDA granted Fast Track designation to the Company’s ARDS program.

“Progressing from an FDA authorization to a site activation in just a few weeks is a tremendous achievement,” commented Dr. Anthony Ting, PhD, Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs at Athersys. “This was only possible due to the diligent effort performed by UH Cleveland and its dedicated staff.  

“We are hopeful that MultiStem can provide a meaningful therapeutic benefit to critically ill patients with COVID-19 induced ARDS,” concluded Dr. Ting.

The primary efficacy endpoint for the MACOVIA study will be number of ventilator-free days through day 28 as compared to placebo, and the secondary objectives are to evaluate clinical parameters (e.g., time in the intensive care unit), pulmonary function, all-cause mortality, tolerability and quality of life (QoL) among survivors. The study is designed to enroll approximately 400 subjects and will be conducted at leading pulmonary critical care centers throughout the United States.

MultiStem 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 advance the development of MultiStem to treat patients with ARDS resulting from the COVID-19 epidemic and other potential pandemic outbreaks.

For more detailed information on the Company’s ARDS program, please visit the ARDS page on the Athersys website.

News release produced by Atherstys, Inc.

ARDS 
ARDS is a serious respiratory condition characterized by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, trauma or other events and represents a major cause of morbidity and mortality in the critical care setting. ARDS is associated with a high mortality rate and significant long-term complications and disability among survivors. Among survivors, the condition prolongs ICU and hospital stays and often requires extended convalescence in the hospital and rehabilitation care settings. There are limited interventions and no effective drug treatments for ARDS. There is a large unmet need for a safe treatment that can reduce mortality and improve Quality of Life (QoL) for those surviving ARDS. Additionally, given the high healthcare resource burden associated with treatment of ARDS patients, a successful therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator and in the ICU, or in the setting of a widespread high pathogenicity respiratory virus pandemic, make those resources more rapidly available to other patients.

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.