GI tract represents the most common target organ of adverse drug reactions (35% of clinical AEs). Clinical safety failures are only predicted by nonclinical studies 25% of the time. Why?
- Lack of predictable in vitro models
- Rodents show low concordance (42%) with human clinical outcomes4
- Non-human primates are more predictive, but limited by cost, throughput, and ethics (reserved for lead)4
There is a significant unmet need for human models of GI risk assessment that can be utilized for drug optimization in early development. We review a solution with high quality Human GI stem cell platform, diverse donor demographics (age, race, sex), and rigorous quality control of all cell lots.