Preclinical Studies
PRECLINICAL TESTING STRATEGY
Ausio has conducted a comprehensive series of pharmacologic and safety studies to assess its lead compound, AUS-131, for potential use in humans. Studies have been conducted to support the development of both oral and topical formulations of AUS-131.
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 ongoing Phase 2a clinical trials.
TOPICAL PROGRAM
Based on the antioxidant properties and potential dermal benefits, Ausio developed prototype gel and cream formulations of AUS-131 for testing in humans. The formulation success criteria included a) acceptable cosmetic and pharmaceutical status of ingredients, b) solubility, c) chemical and physical stability of compound in formulation, d) in vitro dermal delivery targeting in the skin (Franz cell model), and e) dermal safety in preclinical studies. Clinical studies have been conducted on two prototype formulations and confirm the antiblemish benefits of AUS-131.