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:
Reduction of submental fat
87 percent of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Similarly, 83 percent of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
96 percent of patients had unchanged or improved skin laxity based on the clinician rated Submental Skin Laxity Grading Scale (SMSLG)
97 percent of patients reported improvement in chin and neck definition
Adverse events were primarily of mild to moderate intensity, transient and associated with the treatment area
As previously announced, 71.3 percent of subjects had at least a one-grade improvement on the CR-SMFRS / PR-SMFRS composite and 14.0 percent had at least a two-grade improvement on the same composite measure.
These results are based on a multicenter, 12-month, open-label, Phase IIIb study conducted at 21 sites across the U.S., evaluating 165 adults who received injections of ATX-101 for up to six treatments at four-week intervals. Patients received ATX-101 (2 mg/cm2) by subcutaneous microinjections directly into their SMF, and were evaluated three months after their last treatment. The study population includes females (77.6 percent) and males (22.4 percent) with a mean age of 47, who report at least moderate SMF and dissatisfaction with the appearance of their chin. All Fitzpatrick Skin Types are represented.
"We are encouraged by the interim Phase IIIb results of ATX-101," said Frederick Beddingfield, III, M.D., Ph.D., KYTHERA's chief medical officer. "The results, along with additional data from our ATX-101 clinical development program, support the potential for ATX-101 to enter the market as the only U.S. Food and Drug Administration (FDA)-approved drug for the reduction of double chin."
ATX-101 is the first pharmacological treatment for the reduction of submental fat to be investigated under a rigorous clinical development program with the goal of seeking regulatory approvals worldwide, specifically in the U.S., Canada and Europe. When injected, ATX-101 targets the fat cells, or adipocytes, and destroys and eliminates them.
The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101.
KYTHERA Biopharmaceuticals, Inc.