Headquartered in Cleveland, Ohio, Athersys is a biotech company focused on the development of novel cell therapeutics. With acute respiratory distress syndrome (ARDS) identified as a leading cause of death in COVID-19 patients, Athersys is working fast to launch a pivotal trial of its MultiStem® cell therapy product for the treatment of this life-threatening condition.
MultiStem® is the company’s allogeneic “off-the-shelf” bone marrow-derived stem cell product for the treatment of ARDS.
In January 2020, as COVID-19 cases began to spread beyond China and into other nations worldwide, Athersys was approached by the Biomedical Advanced Research and Development Authority (BARDA). BARDA is a U.S. Department of Health and Human Services office responsible for countermeasures against global threats, including but not limited to bioterrorism, pandemics and emerging diseases.
As a result of these interactions, Atherys’ MultiStem® cell therapy was designated as a “Highly Relevant” therapeutic for COVID-19 by BARDA.
Scalability of Athersys’ MultiStem® Cell Therapy
As noted by Athersys, “After isolation from a qualified donor, the MultiStem product may be expanded on a large scale, unlike other cell types, for future clinical use and stored frozen until needed. Cells obtained from a single donor undergo no genetic manipulation or modification and may be used to produce banks yielding hundreds of thousands to millions of doses of the MultiStem product.”
This scalability makes MultiStem an intriguing approach to managing the health complications related to the global outbreak of COVID-19. Previously, Athersys has reported positive outcomes in other studies using its MultiStem therapy for the treatment of respiratory disease.
As explained by Dr. Gil Van Bokkelen, Chairman and CEO of Athersys:
“Throughout all of 2019, we made important progress in our key clinical programs in stroke and in other areas, as evidenced by the highly promising clinical results from our ARDS program. Those results led to the subsequent Fast Track designation from the FDA. The importance of this program has been reinforced by the recent COVID-19 outbreak, where many patients have subsequently become critically ill with ARDS, which a recent WHO analysis has confirmed is the primary cause of death for these patients.”
Athersys Milestones Related to ARDS
To date, Athersys has achieved several milestones related to the treatment of ARDS, including:
- Completed its exploratory clinical study of MultiStem cell therapy for ARDS and announced positive 28-day and one-year results; MultiStem treated patients reported consistent improvement in quality of life over the one-year evaluation period and showed marked improvements in key clinical metrics, including ICU-free days, ventilator-free days and reduced mortality compared to placebo, especially in patients with pneumonia-induced ARDS
- Advanced through Japanese partner, HEALIOS K.K., its ARDS and ischemic stroke programs, with Healios expecting to finish enrollment of both its ONE-BRIDGE ARDS study and the TREASURE stroke study this year
- Athersys’ ARDS program received Fast Track designation from the U.S. FDA
- Healios ARDS program, using HLCM051 (as the MultiStem cell therapy is designated in Japan), received orphan regenerative medicine designation in Japan
While there is not yet an approved treatment for COVID-19, the scientific, medical and regulatory communities are making heroic efforts to bring out new medicines. Athersys is one of more than a dozen cell therapy companies entering the race to find treatments approaches to the coronavirus and its complications.