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. 2021 Aug 11;8:716266. doi: 10.3389/fmed.2021.716266

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