KYTHERA Says REFINE-1 And REFINE-2 Trials Meet Primary, Secondary Endpoints

(RTTNews) - KYTHERA Biopharmaceuticals, Inc. (KYTH) said Monday that its ATX-101 REFINE-1 and REFINE-2 Phase III trials met all primary and secondary endpoints.

The 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.1 If approved, it will be a first-in-class submental contouring injectable drug.

REFINE-1 and REFINE-2 are two identical multicenter, double-blind, randomized, placebo-controlled trials that enrolled more than 1,000 subjects with moderate to severe submental fat in 70 centers in the U.S. and Canada. Validated clinician- and patient-rating scales were used to evaluate primary efficacy endpoints, assessed 12 weeks after the last treatment.