Cartesian Therapeutics, Inc. (RNAC), a clinical-stage biotechnology company, on Monday announced that it has received written agreement from the U.S. Food and Drug Administration or FDA on the design of its Phase 3 AURORA trial for Descartes-08, an investigational mRNA cell therapy for the treatment of myasthenia gravis or MG.
The Special Protocol Assessment or SPA agreement confirms that the trial design is acceptable to support a future Biologics License Application or BLA for Descartes-08, pending trial results.
The Phase 3 AURORA trial will evaluate Descartes-08 versus a placebo in approximately 100 participants with acetylcholine receptor autoantibody positive MG, using six once-weekly infusions without preconditioning chemotherapy.
The primary endpoint is based on improvements in the MG-Activities of Daily Living or MG-ADL score after four months.
This milestone follows promising Phase 2b results, which showed significant and lasting improvements in MG symptoms.
Descartes-08 was well-tolerated, supporting its use as an outpatient therapy without the need for chemotherapy. Cartesian plans to initiate the Phase 3 trial in the first half of 2025.
Descartes-08 has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for MG and other autoimmune diseases.
Currently, RNAC is trading at $19.17 down by 0.15%.
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