KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced positive interim results from a Phase IIIb, multicenter, open-label study (ATX-101-11-26) of ATX-101 during the "Innovations and Renewals" session of the 11th Anti-Aging Medicine World Congress (AMWC), April 4-6, Monte Carlo, Monaco. The study, presented by investigator Susan Weinkle, MD, FAAD, evaluated the safety and efficacy of ATX-101, a potential first-in-class, non-surgical, injectable drug in Phase III trials for the reduction of unwanted submental fat (SMF), commonly known as "double chin." The results found that ATX-101 is well tolerated and may be effective in reducing SMF by both clinician- and patient-reported outcome measures. AMWC is the world's largest event for global aging management, and attracts aesthetic dermatologists, surgeons and clinicians in the regenerative, preventative and anti-aging medicine industry from more than 95 countries.
“Worldwide, doctors are receiving requests from their patients for a non-surgical way to treat their double chin. The results of this study suggest that microinjections of ATX-101 have an acceptable safety profile and can reduce the appearance of a double chin with high patient satisfaction.”
"The positive interim results are consistent with previous ATX-101 studies," said Weinkle, a board certified dermatologist and affiliate clinical professor at the University of South Florida, Tampa, Fla., U.S. "Worldwide, doctors are receiving requests from their patients for a non-surgical way to treat their double chin. The results of this study suggest that microinjections of ATX-101 have an acceptable safety profile and can reduce the appearance of a double chin with high patient satisfaction."
ATX-101 is a proprietary formulation of synthetically-derived deoxycholic acid (DCA), a molecule found in the body that helps break down dietary fat. In this open-label Phase IIIb study, interim results three months after the last ATX-101 treatment are outlined below. Observations were made using validated rating instruments for which one-grade changes are considered to be clinically meaningful: