Cartesian Therapeutics (RNAC) said Monday the US Food and Drug Administration has agreed to the design of its phase 3 AURORA trial for Descartes-08, its mRNA cell therapy for myasthenia gravis, a chronic autoimmune disorder that causes muscle weakness.
The company said the randomized trial, expected to begin in H1, will compare Descartes-08 to a placebo in about 100 participants with acetylcholine receptor autoantibody-positive myasthenia gravis.
The primary endpoint will measure the percentage of patients with a three-point or greater improvement in myasthenia gravis activities of daily living scores after four months, Cartesian added.
Shares of the company were up 2.9% in recent Monday trading.
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