Kythera Biopharmaceuticals, a clinical-stage biopharmaceutical company, has completed enrolment in Phase III trials of ATX-101, an injectable facial aesthetic drug under clinical investigation for the reduction of submental fat.

ATX-101 is a proprietary formulation of synthetic sodium deoxycholate, a well-characterised component of human bile that is naturally occurring in the body to promote the breakdown of dietary fat.

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The randomised double-blind evaluation of submental fat reduction in ATX-101 treated patients (REFINE)-1 and REFINE-2 trials in the US and Canada enrolled more than 1,000 patients, randomised to ATX-101 or placebo.

Kythera anticipates releasing top-line results from the trials in mid-2013.

Kythera president and CEO Keith Leonard said; "We look forward to continued clinical development of ATX-101 as part of our corporate commitment to develop first-in-class, prescription products that address unmet needs for the aesthetic physician and patient communities."

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The two trials, initiated in March 2012, are designed to evaluate the efficacy, safety and tolerability of ATX-101 for the reduction of moderate-to-severe submental fat.

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The identical double-blind, placebo-controlled trials compare subcutaneous injections of ATX-101 dosed at 2mg/cm2 to similar injections of placebo, with the primary efficacy assessments at 12 weeks after final treatment.

The trials will use clinician-reported scale and a patient-reported scale as a composite to define a responder as a patient who simultaneously achieves a pre-defined threshold of improvement on both the scales.

Secondary endpoints will measure patients’ self-perception related to the appearance of their submental fat, in addition to the MRI-assessed reduction in volume of submental fat in a subset of approximately 400 subjects at selected centres.