Kythera Biopharmaceuticals presented additional efficacy data from a Phase 2b study evaluating ATX-101 for the reduction of submental fat. In this double-blind, placebo-controlled, dose-ranging study, 129 patients received ATX-101 1mg/cm2 or 2mg/cm2 or placebo, administered monthly for up to 5 months into the submental area. The expanded analysis focused on additional patient reported outcome measures, including instruments measuring submental fat impact, subject global assessments and subject self-ratings of chin attractiveness.
Additional outcome measures included a Patient-Reported Submental Fat Impact Scale (PR-SMFIS), which was developed to assess whether subjects perceived themselves to be happier, less bothered, less self-conscious, less embarrassed, younger or less overweight after treatment with ATX-101. A statistically significant difference for the 2mg/cm2 dose was achieved relative to placebo for all PR-SMFIS measures, as well as a composite PR-SMFIS score (p<0.05, Week 32).
ATX-101 is an injectable adipolytic agent being studied for the reduction of small volumes of fat, including submental fat. It is based on an endogenous molecule with unique features, including selectivity for adipocytes and rapid clearance.
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