Healios has reported positive top-line results from the open-label ONE-BRIDGE clinical trial of MultiStem cell therapy (HLCM051/invimestrocel) in patients with acute respiratory distress syndrome (ARDS) in Japan.
A somatic stem cell regenerative medicine candidate, HLCM051 was obtained by Healios under an exclusive licensing deal with US-based Athersys.
ONE-BRIDGE is a two-part trial, in which Cohort 1 involved 30 pneumonia-induced ARDS patients while Cohort 2 enrolled five Covid-19-related ARDS patients. Participants were given HLCM051 or standard therapy.
While the first cohort assessed both safety and efficacy, the second cohort evaluated only the safety of the cell therapy.
The number of days without a ventilator (VFD) out of the 28 days following the treatment was the primary endpoint in Cohort 1. The secondary endpoint was 90-day mortality.
A median difference of nine days in the VFD was reported between the treatment arms, with HLCM051 leading to 20 VFD and standard therapy demonstrating 11 VFD.
In addition, the mortality rate 90 days after the treatment in the HLCM051 arm was 39% lesser than in the standard therapy arm, observed to be 26.3% versus 42.9%, respectively.
All Cohort 2 subjects on HLCM051 were discharged with no specific safety concerns. The VFD in this group was 25 days and mortality was 0%.
Healios chairman and CEO Dr Hardy TS Kagimoto said: “Further, with respect to the five patients with severe Covid-19 who were included in this study, no deaths were reported, and all five patients were taken off the ventilator within 28 days after administration.
“Three of these Covid-19-induced ARDS patients were able to have the ventilator removed within three days of intubation.”
Trial lead investigator Dr Kazuya Ichikado added that even though a small number of Covid-19 patients were recruited for the study, the data suggest that HLCM051 can be safe for the treatment of severe infection.
These trial results are consistent with the data from Athersys’s placebo-controlled MUST-ARDS trial performed in a similar patient population in the US and the UK.
Currently, Athersys is carrying out the MACoVIA trial to assess the cell therapy for ARDS caused by Covid-19 and other infections.
Cell & Gene Therapy Coverage on Clinical Trials Arena supported by Cytiva.
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