KYTHERA Biopharmaceuticals, Inc. ("KYTHERA") and Intendis, Bayer HealthCare's dermatology business, today announced the initiation of two European Phase III studies evaluating ATX-101, a first-in-class injectable adipolytic agent, for the reduction of localized fat under the chin (submental fat).
The two multi-center, randomized, double-blind, placebo-controlled, Phase III studies will enroll approximately 720 patients total to assess safety, tolerability and efficacy of ATX-101 versus placebo in the reduction of submental fat. The studies will assess multiple physician and patient-reported efficacy endpoints and are being conducted in approximately 64 centers across the United Kingdom, France, Germany, Belgium, Spain and Italy.
"I am delighted to be involved in the ATX-101 Phase III clinical development program, which I believe to be an important advancement in the area of aesthetic medicine," said Jean Paul Ortonne, MD, dermatologist and ATX-101 clinical investigator in France. "There is a huge demand for a safe, effective and approved injectable treatment for localized fat reduction. These Phase III studies are positive steps toward providing patients with a well-studied, clinically-proven treatment to reduce localized submental fat without surgery."
In two previously conducted ex-US Phase II studies, ATX-101 was well-tolerated and yielded statistically significant reduction of submental fat compared to placebo based on physician and patient assessments. Additionally, KYTHERA, in late 2010, completed a Phase IIB study in the United States and will be releasing data later in 2011.
"We are very pleased with the progress that has been made in Europe with ATX-101," said Keith Leonard, KYTHERA's President and CEO. "The initiation of these Phase III studies marks an important milestone in our collaboration with Intendis and further demonstrates the potential of ATX-101 as a first-in-class injectable drug for localized fat reduction."
"ATX-101 represents a promising product for Intendis to enter the growing aesthetic market," said Marc Lafeuille, President and CEO of Intendis. "We are very pleased to progress to Phase III development of ATX-101, where we are hopeful that the product will reduce localized submental fat as expected."
KYTHERA announced last August a licensing and development agreement granting Intendis commercialization rights to ATX-101 outside of the US and Canada. The strategic partnership deal, which could be worth up to $373 million, marked Intendis' entry into aesthetic dermatology. KYTHERA and Intendis are collaborating on the development of ATX-101 in Europe.