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Preclinical Studies

PRECLINICAL TESTING STRATEGY

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

ORAL PRECLINICAL PROGRAM

Results of several preclinical studies support the potential efficacy of AUS-131 for the treatment of vasomotor symptoms (VMS) and benign prostatic hyperplasia (BPH). 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 rat 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 rodent and non-rodent 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

Results of these studies support the safety of AUS-131 in the Phase 1 studies that have been completed as well as the Phase 2a clinical trials.

 
   

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