Los Angeles — Kythera Biopharmaceuticals, based here, and Intendis, Bayer HealthCare’s dermatology arm, have begun two European phase 3 studies to evaluate ATX-101, an injectable adipolytic agent for reducing localized submental fat, BusinessWire.com reports.
The two multicenter studies will enroll about 720 patients to assess safety, tolerability and efficacy of ATX-101 versus placebo. The studies are being conducted in 64 centers in the United Kingdom, France, Germany, Belgium, Spain and Italy.
In two previously conducted phase 2 studies, ATX-101 was well-tolerated and displayed statistically significant ability to reduce submental fat compared with placebo. Kythera also completed a phase 2B study in the United States in late 2010 and will release the results later this year.
In August, Kythera announced an agreement granting Intendis commercialization rights to ATX-101 outside the United States and Canada. The deal marked Intendis’ entry into aesthetic dermatology.
