Kythera Biopharmaceuticals Inc. (KYTH) Saturday presented positive results that found MRI measurements of patients treated with ATX-101 demonstrated a statistically significant reduction in submental fat, or SMF, commonly known as double chin, during an oral session at The Aesthetic Meeting 2013, organized by the American Society for Aesthetic Plastic Surgery (ASAPS), April 11-16, New York.
Magnetic Resonance Imaging, or MRI assessments were performed in the study as a quantifiable and objective measure of submental fat volume and thickness. The same study also showed positive results based on validated clinician- and patient-reported outcome measures.
The results are from a Phase IIb randomized, double-blind, placebo-controlled study (ATX-101-09-15) to evaluate the safety and efficacy of ATX-101, a potential first-in-class, non-surgical, injectable drug currently in Phase III clinical trials in the U.S. and Canada for the reduction of SMF.
ATX-101 is a proprietary formulation of synthetically-derived deoxycholic acid (DCA), which is an endogenous molecule that aids in the breakdown of dietary fat.
Results from the Phase IIb study showed that patients treated with 2 mg/cm2 of ATX-101:
- achieved statistically significant reduction in submental fat thickness as measured from baseline vs. placebo based on MRI (p<0.05 and p<0.001, week 16 and 32, respectively)
- statistically significant improvement in self-evaluated visual and psychological impact of submental fat vs. placebo based on Patient-Reported Submental Fat Impact Scale.
Most adverse events were of mild to moderate intensity, transient and primarily associated with the treatment area.
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