Athersys, Inc. (NASDAQ: ATHX) partner, HEALIOS K.K. (Healios) has revealed topline results for its Japan ischemic stroke study, TREASURE. In the study, the patients with moderate to moderate-severe ischemic stroke (baseline NIHSS 8-20) received a single dose of MultiStem cells or placebo by intravenous infusion within 18-36 hours of the occurrence. The trial registered 206 patients and was conducted at 48 sites in Japan.
Athersys, Inc disclosed that the preliminary data analyses point to a road ahead for our Japanese partner, Healios, and give us more assurance in our MASTERS-2 Phase 3 ischemic stroke research, which is being done in the US, Europe, and Asia-Pacific. The company is looking forward to continuing to collaborate with Healios to deliver this vital medicine to the Japanese market.
The TREASURE trial offers a significant amount of new information about the MultiStem treatment impact in elderly patients, aged 80 and up, who were not previously studied in MASTERS-1 and are projected to make up a small percentage of the ongoing MASTERS-2 investigation. At the same time, it provides critical information for validating and modifying MASTERS-2 study expectations.
Furthermore, Athersys and Healio’s teams intend to continue analyzing the TREASURE results, including the influence on biomarkers and a more extensive review of critical aspects linked with the treatment effect, among other things. Additionally, Athersys intends to facilitate regulatory engagement, including collaboration with Healios in Japan, to move the ischemic stroke program along the regulatory road.