Cold agglutinin disease (CAD) is a clonal B-cell lymphoproliferative disorder and a rare subgroup of autoimmune hemolytic anemia (AIHA). CAD accounts for 15–25% of AIHA and affects mainly middle aged or older individuals. The disease is characterized by the production of autoantibodies by bone marrow-derived clonal B cells which attach to erythrocytes when exposed to cold temperatures (0–4°C), causing agglutination and eventual immune-mediated hemolysis.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
Published: 19 August 2021
Number of pages:26
This Market Spotlight report covers the Cold Agglutinin Disease market, comprising key pipeline drugs, clinical trials, recent events and analyst opinion, probability of success, and an epidemiology overview.
There are only three industry-sponsored drugs in active clinical development for cold agglutinin disease, with one drug each in Phase I, Phase II, and the NDA/BLA phase.
Therapies in development for cold agglutinin disease target the complement pathway. These pipeline drugs are administered via the intraocular, subretinal, subconjunctival, intravenous, and subcutaneous routes.
The overall likelihood of approval of a Phase I marrow or peripheral blood stimulator asset is 21.7%, and the average probability a drug advances from Phase III is 82.2%. Drugs, on average, take 10.4 years from Phase I to approval, compared to 9.8 years in the overall hematology space.
The distribution of clinical trials across Phase I–III indicates that the majority of trials for cold agglutinin disease have been in the early and mid-phases of development, with 70% of trials in Phase I–II, and 30% in Phase III.
Sanofi has two ongoing trials in cold agglutinin disease.
Sanofi leads industry sponsors with the highest overall number of clinical trials for cold agglutinin disease
16 RECENT EVENTS AND ANALYST OPINION
16 Sutimlimab for Autoimmune Hemolytic Anemia (June 11, 2021)
17 Sutimlimab for Autoimmune Hemolytic Anemia (November 14, 2020)
19 PROBABILITY OF SUCCESS
20 CLINICAL TRIAL LANDSCAPE
21 Sponsors by status
21 Sponsors by phase
22 Recent events
LIST OF FIGURES
12 Figure 1: Overview of pipeline drugs for cold agglutinin disease in the US
12 Figure 2: Pipeline drugs for cold agglutinin disease, by company
13 Figure 3: Pipeline drugs for cold agglutinin disease, by drug type
13 Figure 4: Pipeline drugs for cold agglutinin disease, by classification
17 Figure 5: Sutimlimab for Autoimmune Hemolytic Anemia (June 11, 2021): Phase III – Cadenza (Cold Agglutinin Disease)
19 Figure 6: Probability of success in the marrow or peripheral blood stimulator pipeline
20 Figure 7: Clinical trials in cold agglutinin disease
20 Figure 8: Top 10 drugs for clinical trials in cold agglutinin disease
21 Figure 9: Top 10 companies for clinical trials in cold agglutinin disease
21 Figure 10: Cold agglutinin disease trials status
22 Figure 11: Cold agglutinin disease trials sponsors, by phase
LIST OF TABLES
14 Table 1: Pipeline drugs for cold agglutinin disease in the US
16 Table 2: Sutimlimab for Autoimmune Hemolytic Anemia (June 11, 2021)
18 Table 3: Sutimlimab for Autoimmune Hemolytic Anemia (November 14, 2020)
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