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▎WuXi AppTec content team editor A few days ago, Sanofi announced that its potential "first-in-class" complement C1s protein inhibitor sutimlimab is a pivotal phase 3 clinical trial in the treatment of patients with cold agglutinin disease (CAD) It can quickly and continuously inhibit the hemolysis caused by C1 activation in CAD patients, and it can also provide clinically significant improvements in patients' hemoglobin levels and fatigue
.
Sanofi plans to submit a Biologics License Application (BLA) to the US FDA in the second half of this year
.
The press release stated that if approved, it is expected to be the first approved treatment for hemolysis in CAD patients
.
Sutimlimab is a monoclonal antibody that targets the C1s protein of complement.
It is one of Sanofi's key research therapies
.
The complement system cascade mediates a variety of autoimmune diseases.
By blocking the function of the C1s protein in the classical complement pathway, sutimlimab is expected to treat a variety of autoimmune diseases
.
The randomized, double-blind, placebo-controlled phase 3 clinical trial called CADENZA is the second phase 3 clinical trial to test the efficacy and safety of sutimlimab in the treatment of CAD patients
.
The results of the test showed that 73% of patients treated with sutimlimab reached the primary composite endpoint, which was characterized by an improvement in hemoglobin level of ≥1.
5 g/dL at a specific assessment time point compared with baseline; no blood transfusion was required during the 5-26th week of treatment; and Avoid other CAD-related therapies
.
CAD is a chronic autoimmune hemolytic anemia, which causes the body's immune system to mistakenly attack healthy red blood cells and cause the red blood cells to rupture (hemolysis)
.
CAD patients may experience chronic anemia, deep fatigue, acute hemolytic crisis, and other potential complications, including an increased risk of thrombotic events and early death
.
"The results of the CADENZA trial and the results of the previously announced phase 3 clinical trial CARDINAL will form the basis for our regulatory application
.
They show that sutimlimab is expected to have a meaningful impact on CAD patients
.
" Sanofi Rare Disease and Rare Blood Disorder Development The person in charge, Dr.
Karin Knobe, said
.
Reference: [1] New pivotal data at EHA 2021 reinforces sutimlimab as a first-in-class investigational C1s inhibitor with the potential to be the first approved treatment for hemolysis in people with CAD, a serious and chronic autoimmune hemolytic anemia.
Retrieved June 13, 2021, from https:// Note: This article aims to introduce the progress of medical and health research , Is not a treatment plan recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
.
Sanofi plans to submit a Biologics License Application (BLA) to the US FDA in the second half of this year
.
The press release stated that if approved, it is expected to be the first approved treatment for hemolysis in CAD patients
.
Sutimlimab is a monoclonal antibody that targets the C1s protein of complement.
It is one of Sanofi's key research therapies
.
The complement system cascade mediates a variety of autoimmune diseases.
By blocking the function of the C1s protein in the classical complement pathway, sutimlimab is expected to treat a variety of autoimmune diseases
.
The randomized, double-blind, placebo-controlled phase 3 clinical trial called CADENZA is the second phase 3 clinical trial to test the efficacy and safety of sutimlimab in the treatment of CAD patients
.
The results of the test showed that 73% of patients treated with sutimlimab reached the primary composite endpoint, which was characterized by an improvement in hemoglobin level of ≥1.
5 g/dL at a specific assessment time point compared with baseline; no blood transfusion was required during the 5-26th week of treatment; and Avoid other CAD-related therapies
.
CAD is a chronic autoimmune hemolytic anemia, which causes the body's immune system to mistakenly attack healthy red blood cells and cause the red blood cells to rupture (hemolysis)
.
CAD patients may experience chronic anemia, deep fatigue, acute hemolytic crisis, and other potential complications, including an increased risk of thrombotic events and early death
.
"The results of the CADENZA trial and the results of the previously announced phase 3 clinical trial CARDINAL will form the basis for our regulatory application
.
They show that sutimlimab is expected to have a meaningful impact on CAD patients
.
" Sanofi Rare Disease and Rare Blood Disorder Development The person in charge, Dr.
Karin Knobe, said
.
Reference: [1] New pivotal data at EHA 2021 reinforces sutimlimab as a first-in-class investigational C1s inhibitor with the potential to be the first approved treatment for hemolysis in people with CAD, a serious and chronic autoimmune hemolytic anemia.
Retrieved June 13, 2021, from https:// Note: This article aims to introduce the progress of medical and health research , Is not a treatment plan recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
