Athersys announces DSMB analysis of MASTERS-2 trial, enters MOU with Healios

Athersys announced that the independent data safety monitoring board, or DSMB, has completed a pre-planned interim analysis of the company’s ongoing Phase 3 MASTERS-2 pivotal clinical trial evaluating MultiStem for the treatment of acute moderate-to-severe ischemic stroke, and concluded that the current sample size of 300 patients is insufficiently powered to achieve the primary endpoint of mRS Shift analysis at Day 365. There were no safety issues identified. Because the sample size required to achieve statistical significance is considerably larger, Athersys intends to conduct additional data analysis with independent statisticians. The company plans to pause enrollment of new patients while this analysis is being conducted. Separately, Athersys announces that it has entered into a Memorandum of Understanding, or MOU, granting Healios global rights to develop and commercialize MultiStem for the treatment of acute respiratory distress syndrome, or ARDS. Under the terms of the MOU, Athersys will receive between $1.5M and $4.5M in near term payments with up to $150M in potential development and sales milestones and additional royalties. Athersys also expects to receive revenue from the sale of existing clinical doses of MultiStem, which were manufactured in accordance with its 3D bioreactor process that earlier this year received approval from Japan’s Pharmaceuticals and Medical Devices Agency, for Healios to use in its Phase 3 clinical trial in ARDS.