Maxim Reaffirms Athersys (ATHX) at 'Buy'; FDA's MultiStem Message Consistent with Global Regulators
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Maxim affirms Athersys, Inc. (Nasdaq: ATHX) at Buy with a price target of $10 after the company announced that it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design and planned analysis of a Phase 3 clinical trial of Athersys’ novel MultiStem cell therapy product for the treatment of ischemic stroke.
The firm noted on Wednesday:
- MASTERS-2: MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2 gets an SPA. We view this as a key positive announcement as it means that one single trial (plus any supporting data from the prior phase II study and/or the results from the Healios [Japan] study) will qualify for approval.
- We view the FDA decision as consistent with the message we are hearing from regulators in the U.S., EU, and Japan: Cell Therapy is safe. As such, the burden of the trials is focused on efficacy and demonstrating a significant P-value around the primary endpoint.
- The U.S. trial's design is almost identical to Japan's except that the primary endpoint in the U.S. trial will be a shift analysis, and the secondary endpoint will be "excellent outcomes" (Japan's trial is the opposite).
- Primary endpoint: A difference (P-Value) in the mRS shift analysis. This metric considers "disability across the full spectrum, enabling recognition of large and small improvements in disability and differences in mortality and other serious outcomes, among strokes of different severities." It is based on disability using a Modified Rankin Score at three months.
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