Kythera Initiates Phase 3 trials for Investigational Injectable

Kythera Biopharmaceuticals has initiated two Phase 3 trials of ATX-101, a first-in-class injectable drug under clinical investigation for the reduction of submental fat. The Phase 3 trials, known as REFINE-1 and REFINE-2 (Randomized Double-blind Evaluation of Submental Fat Reduction IN ATX-101 TrEated Patients), will assess the efficacy, safety and tolerability of ATX-101 (2 mg/cm2) subcutaneous injections versus placebo for the reduction of localized subcutaneous fat in the submental area as measured from baseline to 12 weeks after final treatment. The trials will be conducted in approximately 70 centers across the U.S. and Canada and will enroll a total of 1,000 patients, randomized (1:1) to ATX-101 or placebo.