ATX 101 meets Phase III endpoints for submental fat (double chin)
Kythera Biopharmaceuticals, Inc. announced that its ATX-101 REFINE-1 and REFINE-2 Phase III trials met all primary and secondary endpoints. These two pivotal Phase III trials were conducted in the U.S. and Canada to compare the efficacy and safety of a 2 mg/cm2 dose of ATX-101 versus placebo for the reduction of submental fat, which commonly presents as a double chin. ATX-101 is a proprietary formulation of a purified synthetic version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat. If approved, it will be a first-in-class submental contouring injectable drug.
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