Sanofi’s sutimlimab successful in late-stage cold agglutinin disease study

A Phase 3 clinical trial, CARDINAL, evaluating Sanofi’s (NASDAQ:SNY) sutimlimab (BIVV009) in patients with primary cold agglutinin disease (CAD) met the primary and secondary endpoints. The results were presented at ASH in Orlando.

The primary efficacy endpoint was the response rate as measured by a composite of an increase in hemoglobin from baseline or reaching a certain hemoglobin level at week 26 and the absence of transfusions from week 5 to 26.

54% (n=13/24) of subjects met the composite criteria and 63% (n=15/24) achieved hemoglobin levels of at least 12 g/dL (normal range for men and women: 13.5 – 17.5 g/dL and 12.0 – 15.5 g/dL, respectively). 83% (n=20/24) achieved clinically significant improvements in hemoglobin levels.

On the safety front, 29% (n=7/24) of patients experienced at least one serious adverse event, none considered related to the study drug.

Sutimlimab is a humanized monoclonal antibody that binds to (inhibits) a complement-specific serine protease enzyme called C1s that plays a key role in the mechanism of hemolysis in CAD, a rare autoimmune disorder in which the body’s immune system destroys red blood cells.

The company plans to file marketing applications in the near future. The indication has Breakthrough Therapy status in the U.S.

#ASH19

https://seekingalpha.com/news/3525094-sanofis-sutimlimab-successful-in-late-stage-cold-agglutinin-disease-study