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, nonsteroidal, nonhormonal, selective ER beta agonist that has the potential to provide therapeutic benefits with an excellent safety profile compared to estrogen. AUS-131 is being evaluated for a wide range of indications, including menopausal symptoms, benign prostatic hyperplasia, osteoporosis, and topical applications.
About Ausio (www.ausiopharma.com)
Ausio Pharmaceuticals, LLC is a global biotechnology development company committed to cultivating key partnerships with the goal of advancing medicines for an aging population. Ausio was founded in 2006 based on technologies licensed from the Australian Health and Nutrition Association Ltd, NSW, Australia and Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio and has garnered strong patent position for its lead compound, AUS-131.
CONTACT: Dr Richard Jackson of Ausio Pharmaceuticals, LLC,
Web site: http://www.ausiopharma.com/