This Market Spotlight report covers the Cold Agglutinin Disease market, comprising disease background and treatment information, key pipeline drugs, clinical trials, probability of success, licensing and acquisition deals, and an epidemiology overview.
- There are only two industry-sponsored drugs in active clinical development for cold agglutinin disease, with one drug each in Phase II and Phase III
- Therapies in development for cold agglutinin disease target the complement pathway. These pipeline drugs are administered via the intravenous, and intraocular/subretinal/subconjunctival/intravenous/subcutaneous routes.
- The overall likelihood of approval of a Phase I autoimmune/immunology-other asset is 22.3%, and the average probability a drug advances from Phase III is 71.7%. Drugs, on average, take 9.8 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.
- There have been only two licensing and asset acquisition deals involving cold agglutinin disease drugs during 2015-20. The largest deal was the $825m agreement in 2017 between Bioverativ and True North Therapeutics for the acquisition of TNT009 (now referred to as BIVV009 or sutimlimab).
- 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 62.5% of trials in Phase I-II, and 37.5% in Phase III.
- The majority of clinical trial activity in the cold agglutinin disease space comprises completed trials.
- Sanofi leads industry sponsors with the highest number of clinical trials for cold agglutinin disease.
Key Topics Covered:
3. KEY TAKEAWAYS
4. DISEASE BACKGROUND
- Disease definition
- Patient subtypes
- Risk factors
- Non-pharmacological treatment
- Pharmacological treatment
7. PIPELINE DRUGS
8. PROBABILITY OF SUCCESS
9. LICENSING AND ASSET ACQUISITION DEALS
10. PARENT PATENTS
11. CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
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