Initial results from preclinical and Phase 1 safety studies, and plans for Phase 2 studies for menopausal symptoms and benign prostatic hyperplasia (BPH) are to be presented
CINCINNATI, May 14 /PRNewswire/ -- Ausio Pharmaceuticals, LLC, a biotechnology development company focused on medicines for an aging global population, will lead off the Bio(R) Business Forum in a presentation on May 19, 2009 at 9:00 AM in Atlanta, Georgia. Ausio has developed AUS-131, a pharmaceutical formulation of the soy metabolite S-equol. AUS-131 is expected to provide soy health benefits by consistently delivering therapeutically appropriate levels of S-equol, validated in clinical trial programs. Ausio has successfully completed two Phase 1 clinical trials for AUS-131, and Phase 2 studies are scheduled for treatment of menopausal symptoms and BPH.
AUS-131 Preclinical and Phase 1 Clinical Results
AUS-131 is pure, synthetic S-equol, a soy metabolite, and acts as a nonsteroidal, nonhormonal, selective estrogen receptor beta (ER beta) agonist. The safety profile of AUS-131 in FDA-required preclinical studies was excellent, and AUS-131 has demonstrated positive effects in rodent models of menopausal hot flashes and BPH, supporting its promise for the treatment of these conditions in humans. In Phase 1 trials, AUS-131 demonstrated a favorable safety and pharmacokinetic profile, with no significant drug-related adverse events at doses several-fold higher than the expected therapeutic range.
Phase 2 clinical trials to assess the efficacy of AUS-131 for relief of menopausal symptoms and BPH are on schedule to begin September 2009. The expected completion date for the Phase 2 clinical trials is Q2 2010.
AUS-131 is pure, synthetic S-equol, a potent metabolite of the soy isoflavone, daidzein, which is produced in only a subset of individuals. AUS-131 is a first-in-class
|SOURCE Ausio Pharmaceuticals, LLC|
Copyright©2009 PR Newswire.
All rights reserved