Sutimlimab

Generic Name
Sutimlimab
Brand Names
Enjaymo
Drug Type
Biotech
Chemical Formula
-
CAS Number
2049079-64-1
Unique Ingredient Identifier
GNWE7KJ995
Background

Cold agglutinin disease (CAD) is a type of autoimmune hemolytic anemia (AIHA) in which autoantibodies directed against red blood cell surface antigens cause hemolysis at low (3-4°C) temperatures. This cold subtype accounts for approximately 15-25% of all AIHA and is more common in the elderly. In approximately 90% of cases, patients develop immunoglobulin M (IgM) autoantibodies towards the I antigen on erythrocytes - these antibodies react optimally at 4°C and are therefore referred to as "cold agglutinin". Hemolysis in patients with CAD is driven by complement activation, which initiates a cascade that ultimately leads to both intra- and extravascular hemolysis. The most common presenting symptoms in patients with CAD are chronic anemia, acrocyanosis, and Raynaud phenomenon.

Treatment options for patients with CAD are limited. In addition to non-pharmacological strategies, such as counseling patients to keep warm and the use of red blood cell transfusions, approximately 70% of patients require pharmacological treatment. Pharmacologic strategies have included the targeting of B-cells with agents like rituximab, as well as targeting of the complement system with drugs like eculizumab, an anti-C5 mAb, and pegcetacoplan, a novel inhibitor of C3. Notably, none of these agents are approved for use in the treatment of CAD.

Sutimlimab is a first-in-class humanized monoclonal antibody targeted at complement subunit C1s, which is responsible for activating the classic complement pathway. It received FDA approval in February 2022, under the brand name Enjamyo (sutimlimab-jome), becoming the first approved therapy for patients with CAD. Sutimlimab was also approved by the European Commission in November 2022.

Indication

Sutimlimab is indicated to treat hemolysis in adults with cold agglutinin disease (CAD) and decrease the need for red blood cell transfusion in these patients.

Associated Conditions
Hemolysis
Associated Therapies
-

Cold Agglutinin Disease Real World Evidence Registry

First Posted Date
2023-03-30
Last Posted Date
2024-03-28
Lead Sponsor
Sanofi
Target Recruit Count
400
Registration Number
NCT05791708
Locations
🇺🇸

Mission Hope Medical Oncology Site Number : 1241, Santa Maria, California, United States

🇺🇸

Hematology Oncology Associates, PC Site Number : 1211, Medford, Oregon, United States

🇫🇷

Investigational Site Number : 3211, CHALON SUR SAONE Cedex, France

and more 65 locations

Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan

Phase 3
Completed
Conditions
Interventions
First Posted Date
2021-11-24
Last Posted Date
2023-10-03
Lead Sponsor
Sanofi
Target Recruit Count
7
Registration Number
NCT05132127
Locations
🇯🇵

Investigational Site Number 3920003, Osaka, Japan

🇯🇵

Investigational Site Number 3920002, Saitama, Japan

🇯🇵

Investigational Site Number 3920001, Tokyo, Japan

and more 2 locations
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