In early August, via a press release, biotechnology company Athersys, Inc. shared that its Japanese partner, biotechnology company HEALIOS K.K. (“Healios”), recently released positive topline data from a medical study evaluating invimestrocel (HLCM051 / MultiStem) for patients with acute respiratory distress syndrome (ARDS). Within the Phase 2 ONE-BRIDGE clinical trial, invimestrocel helped reduce ARDS-related mortality by approximately 39%. Interested in learning more about the results? Take a look at this information provided by Healios.
Acute Respiratory Distress Syndrome (ARDS)
Normally, a protective membrane on blood vessels prevents fluid from leaking out. However, in acute respiratory distress syndrome (ARDS), some sort of illness or injury damages this protective membrane, causing fluid to leak into alveoli in the lungs. As a result, this serious lung disease prevents oxygen from reaching the lungs and blood and causes the lungs to stiffen. Ultimately, this inability to oxygenate the bodily organs causes a loss of organ function. ARDS usually results from another condition, such as sepsis, pneumonia, lung transplants, or pancreatitis. Most recently, and in the ONE-BRIDGE study, ARDS has been linked to COVID-19. Regardless, ARDS typically affects older individuals, and symptoms appear within a few days of the other injury or illness. Unfortunately, there are few available – or effective – therapeutic options. Symptoms include:
- Low blood pressure
- Rapid breathing and/or hyperventilating
- Pallor (extremely pale skin)
- Extreme fatigue
- Severe shortness of breath and/or difficulty breathing
- Cyanosis (blue tint to the skin, nails, and lips)
- Organ failure
Altogether, the Phase 2 ONE-BRIDGE sought to understand the safety, efficacy, and tolerability of invimestrocel for two patient cohorts with ARDS. In the first patient cohort, data was sourced from 30 patients whose ARDS resulted from pneumonia. Alternately, the second cohort included five patients whose ARDS resulted from COVID-19. Patients were treated with invimestrocel (MultiStem), which was described by Helios as:
A somatic stem cell regenerative medicine product.
Athersys further explains that:
MultiStem…is developed from a special class of stem cells called Multipotent Adult Progenitor Cells (MAPC) [which] are obtained from healthy bone marrow and…may be administered without tissue matching or immune suppression. The cells can express a range of therapeutically relevant proteins…that have the potential to…[reduce] inflammation, [protect] damaged or injured tissue, and [enhance] the formation of new blood vessels in regions of ischemic injury.”
Data from the trial highlights the benefits of invimestrocel, including lower mortality and more ventilator-free days. Additionally, invimestrocel was found to be relatively safe and well-tolerated. So far, invimestrocel has received Orphan Regenerative Medicine Product designation in Japan, as well as Fast Track and Regenerative Medicine Advanced Therapy designations within the U.S. Ultimately, invimestrocel has the potential to become the first approved therapy for use in patients with ARDS, hopefully improving outcomes across the board.