KYTHERA commences two ATX-101 Phase III trials for reduction of submental fat

Mar 5 2012

KYTHERA Biopharmaceuticals, Inc. (KYTHERA), a privately-held biotechnology company focused on the development and commercialization of prescription products in aesthetic medicine, today announced the initiation of two pivotal U.S. Phase III trials of ATX-101, a first-in-class injectable drug under clinical investigation for the reduction of submental (under the chin) fat.

The Phase III trials, known as REFINE-1 and REFINE-2 (Randomized Double-blind Evaluation of Submental Fat Reduction IN ATX-101 TrEated Patients), are the first pivotal prospective, placebo-controlled trials of an injectable fat reduction agent under an active U.S. registration program.

"The design for the REFINE trials is based on multiple prior pre-clinical and clinical trials, which to date have shown encouraging efficacy and safety data for ATX-101," said Patricia S. Walker, M.D., Ph.D., KYTHERA's Chief Medical Officer. "We hope these Phase III trials, as part of our continued clinical investigation of ATX-101, will ultimately lead to a safe, effective and well-studied treatment for the reduction of unwanted submental fat."

Source: KYTHERA Biopharmaceuticals, Inc.