Case Study

Delivering Pre-IND To IND Safety Studies In Just Three Months

Source: Syngene International Ltd.

A biotech company had generated a strong pipeline of candidates for gut-brain diseases and was looking for the right preclinical partner for short and long-term Safety Assessment studies. Syngene’s Safety Assessment team supported the client’s drug development program through multiple exploratory toxicity studies, four IND-enabling safety tox studies, and three 90-day toxicity studies in rodent species. As a result, the biotech company’s Safety Assessment programs advanced from pre-IND to IND in an accelerated time frame of just three months.

The client is a US-based biotech company engaged in cutting-edge research relating to gut-brain biology. By targeting the bidirectional information highway between the gut and brain, the company hopes to influence the brain center involved in diseases with high unmet needs. Diseases linked to the gut-brain include obesity, diabetes, non-alcoholic steatohepatitis (NASH), functional gastrointestinal disorders, inflammatory disorders, depression, autism, and Parkinson’s disease.

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