Table 3.
Non-clinical package proposed for pre-IND/SA.
| Study conducted | Information collected | |
|---|---|---|
| Pharmacology studies | Model selection | Validate the most appropriate model to evaluate the impact of chronic treatment in future in vivo studies |
| Strain selection | Identify a C. minuta candidate strain for further development as an LBP to target obesity | |
| In vivo efficacy | Address the efficacy of the drug candidate | |
| Dose ranging | Identify a putative dose-dependent efficacy of Xla1 | |
| Safety studies | Translocation | Demonstrate that Xla1 does not present any risk of treatment-induced bacterial infection |
| High-dose tolerance and wash out | Evaluate the impact of an acute exposure to the highest concentration technically achievable |