Kythera Biopharmaceuticals announced that it has successfully completed a third Phase 2 study with ATX-101 for the reduction of submental (“under-the-chin”) fat. This randomized, double-blind, placebo-controlled, dose-ranging study showed ATX-101 was well tolerated and demonstrated statistically significant efficacy as compared with placebo. The study enrolled a total of 129 subjects and was conducted across 10 dermatology and plastic surgery centers in the U.S. Multiple clinician and patient endpoints were assessed, as well as MRI to objectively quantify fat reduction. The study tested two drug-dosing regimens (1 and 2 mg/cm2). In this study, ATX-101 demonstrated statistically significant (p<0.05) reductions in submental fat as compared with placebo as assessed by all measures: a validated clinician scale, patient reported outcome scale, and magnetic resonance imaging measurement for both fat volume and thickness.

ATX-101 is an injectable drug 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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