Sanofi (SNY) Unit Says MACI Met Co-Primary Endpoint vs. Microfracture in Phase 3 Trial
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Sanofi US, a unit of Sanofi (NYSE: SNY), announced that its product MACI® (matrix-induced autologous chondrocyte implant) met its co-primary endpoint in a two-year, randomized, controlled clinical trial compared to microfracture, a surgical procedure designed to stimulate the growth of new cartilage. MACI uses a patient's own (autologous) cultured cartilage cells (chondrocytes) to repair articular cartilage defects in the knee joint. The results from this pivotal safety and efficacy phase 3 trial comparing MACI to microfracture (SUMMIT) will be included as part of an ongoing EMA marketing authorization application and as part of a future FDA biologics license application in the United States.
The trial enrolled 144 patients across seven countries in Europe with symptomatic articular cartilage defects in their knees. Analysis of the clinical data showed a statistically significant improvement in the primary endpoint for those patients treated with MACI compared to microfracture. In addition, this difference met the pre-specified threshold for a clinically meaningful difference.
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The trial enrolled 144 patients across seven countries in Europe with symptomatic articular cartilage defects in their knees. Analysis of the clinical data showed a statistically significant improvement in the primary endpoint for those patients treated with MACI compared to microfracture. In addition, this difference met the pre-specified threshold for a clinically meaningful difference.
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