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.
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."
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.
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.