May 5, 2020 -- Athersys announced that it has begun enrollment in its phase II/III study named MultiStem Administration for COVID-19 Induced Acute Respiratory Distress Syndrome (MACOVIA).
Patients were enrolled at University Hospitals Cleveland Medical Center. The program will evaluate the administration of MultiStem for the treatment of acute respiratory distress syndrome (ARDS); the therapy was recently granted fast track designation by the U.S. Food and Drug Administration (FDA) based on promising phase I/II data from its MUST-ARDS trial. As there are currently no FDA-approved medicines for the treatment of ARDS, this therapy could provide an unmet need for COVID-19 patients.
The study will enroll approximately 400 subjects who will receive open-label, single-active treatment to evaluate the safety of MultiStem administered at two dose levels to patients with moderate to severe ARDS associated with COVID-19. If MultiStem is deemed efficacious, safe, and tolerable, the company will further evaluate the treatment with a double-blind, randomized, and placebo-controlled trial protocol.
The company is working with Medpace, a contract research organization, for the study. The firm is also in discussions with the Biomedical Advanced Research and Development Authority (BARDA) to expedite the development of its therapy.