Athersys Inc. (NASDAQ: ATHX) has announced that its Japanese partner HELIOS K.K has announced positive topline data from the ONE-BRIDGE clinical study assessing efficacy and safety of invimestrocel (MultiStem cell therapy) in the treatment of acute respiratory syndrome patients.
Helios release ONE-BRIDGE data
ONE-BRIDGE trial is an open-label study with two patient cohorts conducted in Japan. Healios reported promising topline findings for both cohorts, including the primary outcome of ventilator-free days (VFD) and the secondary outcome of 90-day mortality, in comparison to the registry and expectation for such patients. The findings are consistent with the company’s placebo-controlled MUST-ARDS trial, which was done in the US and the UK with a similar patient group. In Japan, MultiStem cell therapy (HLCM051) has been approved as an orphan regenerative medicine product for treating ARDS.
Interim Athersys CEO William (B.J.) Lehmann, Jr said, ” We are excited by the results reported by our partner, Healios. We continue to believe that MultiStem administration can have a meaningful therapeutic impact for ARDS patients. We look forward to continuing to support Healios as it moves the ARDS program forward in Japan and as we make progress elsewhere.”
Athersys studying MultiStem in ARDS patients
The MACoVIA trial, a double-blind, sham trial investigating MultiStem delivery in patients with ARDS caused by COVID-19 and other infections, is currently underway at Athersys. The US FDA has given Athersys’ ARDS program Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designation.
The potential for multimodal therapeutic impact of multiStem treatment may set it apart from typical biopharmaceutical medicines with a singular mechanism of benefit. MultiStem is a one-of-a-kind “off-the-shelf” regenerative medicine product candidate that can be produced in a scalable manner, kept in frozen form for years, and delivered without the requirement for immune suppression or tissue matching. Based on favorable data, there is potential in MultiStem therapy offering significant benefit to patients.
