Bayer HealthCare’s dermatology business Intendis and KYTHERA Biopharmaceuticals, Inc. 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 primary efficacy endpoints are the reduction of submental fat using a 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and subject satisfaction using a 7-point Subject Self Rating Scale (SSRS). Approximately 64 centers across the United Kingdom, France, Germany, Belgium, Spain and Italy take part in these studies.
Prof. Dr. Jean Paul Ortonne, dermatologist and ATX-101 clinical investigator in France said, I am delighted to be involved in ATX-101 Phase III clinical development program, which I believe to be an important advancement in the aesthetic medicine. 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.
Marc Lafeuille, President and CEO of Intendis said, ATX-101 represents a promising product for Intendis to enter the growing aesthetic dermatology market. 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.
In August 2010, Intendis announced the licensing and development agreement with KYTHERA receiving the commercialization rights to ATX-101 outside of the US and Canada. KYTHERA and Intendis are collaborating on the development of ATX-101 in Europe. Intendis currently plans to launch the product in selected markets in Europe, Asia and Latin America starting in 2014.
ATX-101 is a first-in-class injectable drug being studied for the reduction of small volumes of fat, including submental fat. It is based on a well-studied endogenous molecule with unique features including selectivity for adipocytes and rapid clearance. This minimally invasive procedure, done with little or no anesthetic, has the promise to yield consistent and meaningful clinical results. Clinical studies to date have demonstrated that ATX-101 may effectively reduce localized fat deposits, and is safe and tolerable. Three randomized, double-blind, placebo-controlled Phase II studies with ATX-101 in the reduction of submental fat and two Phase I pharmacokinetic and histology studies have been successfully completed. KYTHERA, in late 2010, completed a Phase IIB trial in the United States and will be releasing data later in 2011.