Athersys Reports That Healios Has Completed Enrollment in the ONE-BRIDGE Study of MultiStem for Acute Respiratory Distress Syndrome in Japan

Athersys, Inc. (Nasdaq: ATHX) announced today that its partner HEALIOS K.K. (Healios) has completed enrollment in the ONE-BRIDGE study in Japan evaluating MultiStem (invimestrocel) in patients with acute respiratory distress syndrome (ARDS) caused by pneumonia.

The ONE-BRIDGE trial consists of two patient cohorts. With cohort 1, the objective is to demonstrate the safety and efficacy of MultiStem treatment for patients with pneumonia-induced ARDS. Cohort 1 was designed as a randomized, open-label study to enroll 30 patients. The primary efficacy endpoint is the number of ventilator-free days in the 28 days following the treatment allocation. Cohort 2 was designed to enroll five patients with COVID-19 induced ARDS with the objective to evaluate the safety of MultiStem treatment in these patients. Healios intends to analyze and evaluate the data after the follow-up period and will make further announcements, as appropriate.

In the United States, Athersys is conducting its own clinical study evaluating MultiStem cell therapy for the treatment of ARDS, the MACOVIA trial. This study includes patients with ARDS due to COVID-19 and other pathogens. The ARDS program was granted both Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations from the United States Food and Drug Administration.

About ARDS

Acute respiratory distress syndrome (ARDS) is a serious immunological and inflammatory condition characterized by widespread inflammation in the lungs. ARDS can be triggered by COVID-19, pneumonia, sepsis, trauma or other events and represents a major cause of morbidity and mortality in the critical care setting. It has significant implications, as it prolongs intensive care unit (ICU) and hospital stays and requires convalescence in the hospital and rehabilitation. There are limited interventions and no effective drug treatments for ARDS, making it an area of high unmet clinical need with high treatment costs. Given these high treatment costs, a successful cell therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator and in the ICU and importantly, could reduce mortality and improve quality of life for those suffering from the condition.