New data reinforces sutimlimab as a first-in-class investigational C1s inhibitor

French pharma major Sanofi (Euronext: SAN) is presenting results from Part A of CADENZA, a pivotal Phase III double-blind, placebo-controlled study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease (CAD) without a recent history of blood transfusion (within the prior six months), at an oral session of the European Hematology Association (EHA) 2021 Congress now taking place virtually.

The data demonstrated treatment with sutimlimab resulted in rapid and sustained inhibition of C1-activated hemolysis in people with CAD, noted within one week of treatment, and clinically-significant improvements in hemoglobin and fatigue when compared to placebo during the course of the study.

“Cold agglutinin disease causes the body’s immune system to mistakenly destroy its healthy red blood cells. People living with cold agglutinin disease experience the crippling impact of chronic hemolysis that can cause severe anemia, profound fatigue and can have acute hemolytic crisis,” said principal investigator and presenting author Professor Alexander Röth, Department of Hematology and Stem Cell Transplantation, University Hospital, University of Duisburg-Essen, Germany. “The positive evidence from the CADENZA trial demonstrate significant improvements in hemolysis and meaningful impact on key measures of anemia and fatigue,” he noted.