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Kythera tests injectable fat reducer

Article-Kythera tests injectable fat reducer

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, 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.

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