Preclinical Studies
PRECLINICAL TESTING STRATEGY
Ausio has conducted a comprehensive series of pharmacologic and safety studies to assess its lead compound, AUS-131, for use in humans.
ORAL PRECLINICAL PROGRAM
Results of several preclinical studies support the potential efficacy and safety of AUS-131. The preclinical safety program included the following studies, conducted in full compliance with the International Conference on Harmonization (ICH) guidelines and Good Laboratory Practices (GLP):
- Genotoxicity battery: bacterial mutation, chromosome aberration, and in vivo micronucleus tests
- Pharmacology and safety studies: respiratory, cardiovascular, and neurotoxicity
- Metabolism studies: protein binding and cytochrome P450 induction and inhibition
- Absorption, distribution, metabolism and excretion studies using radiolabeled AUS-131 in models
- 28-day repeat dose toxicity studies (with recovery period) in rodent and non-rodent models
- Pharmacokinetic studies after single and repeat dose in rodent and non-rodent models using validated, chiral analytical methods