Sanofi (SNY) said sutimlimab met its primary efficacy endpoint in a Phase 3 trial for patients with cold agglutinin disease.
CAD is a severe and chronic rare blood disorder in which the immune system mistakenly attacks a person’s own healthy red blood cells. There are currently no approved treatments, Sanofi said.
A total of 24 patients were enrolled; two withdrew from the study for non-drug related reasons. All 22 patients that completed Part A of the study have enrolled in an ongoing long-term follow-up study.
The primary efficacy outcome was response rate based on a composite of an increase in hemoglobin from baseline or reaching a hemoglobin level at treatment assessment endpoint and the absence of transfusions between weeks 5 to 26.
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