April 15, 2008
LOS ANGELES, April 15, 2008 – Kythera Biopharmaceuticals, Inc. ("Kythera") announced today the initiation of a second Phase II clinical trial evaluating its proprietary product, ATX-101 for the reduction of unwanted submental (under chin) fat. This clinical trial is the second in a series of Phase II studies of ATX-101 in aesthetic applications and is aimed at assessing the safety and effectiveness of ATX-101 as a “liposculpting” agent. The clinical program aims to lead to registration of ATX-101 as an approved prescription drug in the U.S., Europe and Asia.
The multi-center, randomized, double-blind, placebo-controlled, Phase II trial will enroll approximately 60 patients to assess safety, tolerability and efficacy across two dosing paradigms of ATX-101 in reducing small volumes of submental fat. The study will assess multiple physician and patient measured endpoints and is being conducted at centers in the United Kingdom, Canada and Australia.
“Preliminary results from early dosing cohorts from our first Phase II trial have shown that ATX-101 is well tolerated,” said Patricia Walker, MD, PhD, Kythera’s Chief Medical Officer. “Based on these results, Kythera and our investigators look forward to further characterizing the safety and effectiveness profile of ATX-101 prior to progressing to Phase III trials.”
Kythera has completed enrollment in their first Phase II clinical trial for ATX-101 in the treatment of submental fat and has an ongoing U.S. Phase I pharmacokinetic study under a U.S. IND.
“The initiation of this second Phase II trial in the ATX-101 submental fat program is an important milestone for Kythera. It delivers on our promise to conduct rigorous scientific and clinical testing on all of our products,” said Keith Leonard, Kythera’s President and CEO. “It moves us one step closer to meeting consumer and physician demand for a safe, effective, well-studied and approved product for localized fat reduction.”
ATX-101 also has an ongoing Phase II clinical trial in the treatment of superficial lipomas and has completed a multi-dose, dose-escalating Phase I safety and pharmacokinetic study under a U.S. IND.
Kythera established its adipolytic agent program through a broad licensing agreement with Los Angeles Biomedical Institute at Harbor-UCLA Medical Center in 2005. Under the terms of the agreement, Kythera obtained exclusive rights to develop, manufacture and commercialize the ATX-101 compound for all applications in all markets, worldwide.