Athersys, Inc. (Nasdaq: ATHX) announced today that its clinical program evaluating MultiStem® cell therapy for the treatment of Acute Respiratory Distress Syndrome (“ARDS”) has received Fast Track designation from the United States Food and Drug Administration (“FDA”). This important designation is given to qualified investigational therapies that show promise in providing benefit to patients in areas of significant unmet medical need. Fast Track designation allows for an expedited regulatory review process after the clinical data is submitted to help speed development of promising therapies to the market in order to help patients in areas where current standard of care is limited.

In January 2019, the Company announced favorable top-line results from a randomized, double-blind placebo-controlled exploratory Phase 2 clinical study evaluating MultiStem administration to patients with ARDS, referred to as the MUST-ARDS study.  ARDS is a serious and life-threatening pulmonary condition that requires patients to be placed on a ventilator in the intensive care unit (“ICU”) and is associated with a high level of mortality. Many patients that do survive face extended stays in the ICU and experience difficult and challenging recoveries. In the MUST-ARDS study, patients who received MultiStem treatment within several days after being diagnosed with ARDS and being placed on a ventilator experienced lower mortality, increased ventilator-free days, and increased ICU-free days during the initial 28-day clinical assessment period relative to patients receiving placebo.  Additional data from the trial will be presented on May 20, 2019 at the annual American Thoracic Society meeting.  The Company’s collaborator in Japan, HEALIOS K.K., has initiated and is enrolling patients in its clinical trial evaluating administration of MultiStem to pneumonia-induced ARDS patients in Japan. 

In addition to the ARDS Fast Track announcement, Athersys is hosting an Investor Day event today for shareholders, potential investors, analysts and other invited guests to highlight the Company’s capabilities, technologies, research programs, clinical trials and plans.  A summary video from the Investor Day event will be available on the Company’s website approximately one week after the event.

“We are honored to have received Fast Track designation from the FDA for our ARDS program, which supports the promise of our cell therapy for treating patients in an area where new and more effective treatments are needed.  This designation complements other indications where we have received important regulatory designations, including Fast Track and RMAT designations for our ongoing Phase 3 program for ischemic stroke,” commented Dr. Gil Van Bokkelen, Chairman and CEO, at Athersys. “We share the same priorities and goals as the FDA, including putting patient safety and well-being first and foremost, and a desire to see safe and effective new therapies developed in areas where standard of care is limited or simply unavailable for many patients.

“Our Investor Day event will highlight some of the exciting progress we are making in several key areas, and will provide an opportunity for clinical experts, patient advocates, and others to share their perspective alongside members of the Athersys leadership team, and we are truly grateful for the many expressions of support that we have received,” concluded Dr. Gil Van Bokkelen.

Also, on May 20, 2019, Dr. Geoff Bellingan, Medical Director at University College London Hospitals, will be presenting additional data from the exploratory Phase 1/2 ARDS study, (“MUST-ARDS”) at the American Thoracic Society International Conference in Dallas, Texas.  Dr. Bellingan’s talk is titled, “Primary Analysis of a Phase 1/2 Study to Assess MultiStem® Cell Therapy, a Regenerative Advanced Therapy Medicinal Product (ATMP), in Acute Respiratory Distress Syndrome (MUST-ARDS)”.