Athersys gets FDA fast track designation for acute respiratory distress syndrome


Athersys’ (NASDAQ:ATHX) MultiStem cell therapy for the treatment of acute respiratory distress syndrome (ARDS) has received FDA fast track designation.

ARDS is a widespread inflammation of the lungs that can be triggered by pneumonia, sepsis or other trauma. ARDS requires that patients be placed on a ventilator in the intensive care unit (ICU) and is associated with a high level of mortality. There are currently limited interventions and no effective drug treatments for ARDS.

Administered intravenously, MultiStem cell therapy is designed to promote tissue repair and healing by reducing inflammation, supporting tissue regeneration and promoting homeostasis.

“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,” Dr. Gil Van Bokkelen, Athersys’ chairman and CEO, said in a statement.

In January 2019, Athersys announced positive Phase 2 data, where patients who were treated with MultiStem within several days after ARDS diagnosis experienced lower mortality, increased ventilator-free days, and increased ICU-free days during the initial 28-day period, compared to patients receiving placebo.

Athersys plans to present additional data from the trial at the annual American Thoracic Society meeting this month.

Abby Hardy