It is estimated that in 2016, there were approximately 88.5 million prevalent cases of celiac disease worldwide, and forecasts that number to increase to 97.4 million prevalent cases by 2025.
Prevalence of celiac disease is highest in Europe and North America, and lowest in Africa and Oceania.
All industry-sponsored drugs in active clinical development for celiac disease are in Phase I or Phase II. Therapies in development for celiac disease focus on targets such as gluten, interleukin 15 receptor, zonulin and zonulin receptor, OX40/CD134 and OX40L, and T-cell receptor. The majority of pipeline drugs for celiac disease are administered orally, with the remainder being intravenous and intradermal formulations.
High-impact upcoming events for drugs in the celiac disease space include topline Phase III trial results of INN-202. There were six licensing and asset acquisition activities involving celiac disease drugs during 2013-18. The $0.1m agreement between Intrexon and the two startups, Genten Therapeutics and CRS Bio, to develop disease-modifying therapies through Intrexon's proprietary ActoBiotics Lactococcus lactis platform, was the largest deal during 2013-18. This is the only deal with a disclosed deal value.
The clinical trials distribution across Phase I-II indicates that the majority of trials for celiac disease have been in Phase II development, with 90% of trials in Phase II, and only 10% in Phase I.
The US has a substantial lead in the number of celiac disease clinical trials globally. Innovate Biopharmaceuticals has the highest number of completed clinical trials for celiac disease, and also leads industry sponsors with the highest number of Phase II clinical trials for celiac disease.
Key Topics Covered
2. Key Takeaways
3. Disease Background
6. Pipeline Drugs
7. Key Upcoming Events
8. Licensing and Asset Acquisition Deals
8.1 Takeda Funds Celiac Asset as Prelude to Potential Acquisition
9. Parent Patents
10. Clinical Trial Landscape
10.1 Sponsors by Status
10.2 Sponsors by Phase
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