Cartesian Therapeutics, Inc. announced that it has received written agreement from the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process. This agreement pertains to the overall design of the company’s planned Phase 3 AURORA trial for Descartes-08 in myasthenia gravis (MG).
The SPA agreement signifies that the FDA has determined the proposed trial design is acceptable to support a future Biologics License Application (BLA) for Descartes-08 in MG, contingent on the trial's ultimate outcome. This provides critical regulatory clarity and a defined path toward potential market approval.
The Phase 3 AURORA trial is designed as a randomized, double-blind, placebo-controlled study, assessing Descartes-08 in approximately 100 participants with acetylcholine receptor autoantibody positive MG. The trial is expected to commence in the first half of 2025, with a primary endpoint measuring the proportion of participants achieving an improvement in MG-ADL score of three points or more at Month 4.
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