Positive Results from First of Two ATX-101 European Phase III Trials for Reduction of Submental Fat

KYTHERA,  announced the presentation of initial trial results from Study ATX-101-10-16, the first of two pivotal European Phase III clinical trials with ATX-101 (a first-in-class injectable drug being studied for the reduction of localized fat. ATX-101 is a proprietary formulation of deoxycholate (see below structure)  a well-studied endogenous compound that is present in the body), a facial injectable drug for the reduction of unwanted fat under the chin, or submental fat. V. Leroy Young, MD, FACS, presented the initial results at the American Society for Aesthetic Plastic Surgery (ASAPS) 45^th Annual Aesthetic Meeting in Vancouver, British Columbia, on May 4, 2012.

The ATX-101-10-16  trial met its pre-specified primary endpoints based on clinician and patient assessments. At the 2 mg/cm² dose, ATX-101 resulted in a statistically significant reduction of submental fat, relative to placebo, as measured using a 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (mean of 0.90 vs. 0.22; p<0.001, week 24). Similarly, ATX-101 (2 mg/cm²) resulted in a statistically significant percentage of subjects, relative to placebo, achieving a pre-defined categorical change using a 7-point Subject Self Rating Scale (SSRS) (66.1 vs. 28.7; p<0.001, week 24).