KYTHERA Biopharmaceuticals reports positive results from Phase IIb study of ATX-101

Apr 15 2013

KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today presented positive results that found MRI measurements of patients treated with ATX-101 demonstrated a statistically significant reduction in submental fat (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, NY. MRI assessments were performed in the study as a quantifiable and objective measure of submental fat volume and thickness. The same study also demonstrated positive results based on validated clinician- and patient-reported outcome measures. The results are from a Phase IIb, multicenter, 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.

“The MRI results of this study are exciting because they support efficacy results observed by physicians and patients from this and other clinical studies that showed a statistically significant reduction in fat under the chin with an injectable treatment”

"The MRI results of this study are exciting because they support efficacy results observed by physicians and patients from this and other clinical studies that showed a statistically significant reduction in fat under the chin with an injectable treatment," said ATX-101 investigator, Leroy Young, M.D., FACS, a board-certified plastic surgeon in private practice in St. Louis, MO, and past president of the Aesthetic Surgery Education and Research Foundation (ASERF). "Patients also reported that the reduction in submental fat made them feel happier and less self-conscious about their appearance, which is what we strive to achieve in aesthetic medicine."

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 demonstrated:

• Reduction of submental fat
  • Patients 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 (overall impact, p<0.001, week 32)
• Most adverse events were of mild to moderate intensity, transient and primarily associated with the treatment area

These results are based on a multicenter, randomized, double-blind, placebo-controlled Phase IIb study conducted at 10 sites across the U.S. The study evaluated 129 adults who received one of three dosing regimens, ATX-101 1 mg/cm², ATX-101 2 mg/cm², or placebo, administered as a series of microinjections into the submental area for up to six treatment visits at least 28 days apart. The study population includes males and females, aged 18-65, with moderate or severe SMF at baseline as indicated by the validated Clinician-Reported Submental Fat Rating Scale (CR-SMFRS). Subjects expressed dissatisfaction with their face and chin appearance at baseline and exhibited a stable body weight in the six months preceding the study.

"This study brings together clinician- and patient-reported outcomes on validated scales, and an objective measure to demonstrate the aesthetic improvement that results from ATX-101," said Frederick Beddingfield, III, M.D., Ph.D., chief medical officer, KYTHERA Biopharmaceuticals, Inc. "These results, along with the strong interim results from our open-label Phase IIIb trial, support the potential of ATX-101 to enter the market as the first medical aesthetic drug approved for the reduction of submental fat."

SOURCE KYTHERA Biopharmaceuticals, Inc.