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Preclinical Studies



Ausio has conducted a comprehensive series of pharmacologic and safety studies to assess its lead compound, AUS-131, for use in humans.


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

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