Initial trial results from KYTHERA’s second of two Phase III trials with ATX-101

Jun 12 2012

KYTHERA Biopharmaceuticals, Inc. ("KYTHERA") today announced the presentation of initial trial results from Study ATX-101-10-17, the second of two pivotal European Phase III clinical trials with ATX-101, a facial injectable drug for the aesthetic treatment of submental fat, which commonly presents as an undesirable double chin. Ashish Bhatia, MD, presented the results at the 8th Annual Vegas Cosmetic Surgery International Multispecialty Symposium in Las Vegas, Nevada, on June 10, 2012.    

The ATX-101-10-17 trial met its pre-specified primary endpoints based on clinician and patient assessments. At the 2 mg/cm² dose, ATX-101 resulted in a statistically significant reduction of submental fat, relative to placebo, as measured using a 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (mean of 0.77 vs. 0.36; p<0.0001, week 24). Similarly, ATX-101 (2 mg/cm²) resulted in a statistically significant percentage of subjects, relative to placebo, achieving a pre-defined categorical change using a 7-point Subject Self Rating Scale (SSRS) (64.8 % vs. 29.3%; p<0.001, week 24).

"As a physician, I'm enthusiastic about the potential for an 'in-office' facial injectable treatment to reduce our patients' double chins, an issue of increasing concern for our patients, but not easily or effectively treated today," said Dr. Bhatia, a board certified dermatologist and Assistant Professor of Clinical Dermatology at Northwestern University Feinberg School of Medicine, Chicago, IL, who is currently an investigator in the ongoing U.S. pivotal Phase III REFINE trials. "The results from this pivotal European trial are a positive signal in the development of this new injectable for the reduction of submental fat."

Importantly, other Patient Reported Outcomes specific to treatment with ATX-101 (2 mg/cm²) also resulted in statistically significant differences, relative to placebo, in the:

• reduction of submental fat using a 5-point Patient-Reported Submental Fat Rating Scale (PR-SMFRS) (mean of 0.94 vs. 0.41; p<0.0001, week 24); and
• percentage of subjects expressing satisfaction with treatment using the Global Post-Treatment Satisfaction Scale (84.8% vs. 58.1%, p<0.01, week 24).

Additional Patient Reported Outcomes included a Patient-Reported Submental Fat Impact Scale (PR-SMFIS), which was developed to measure the visual and psychological impacts of submental fat, including whether patients perceived themselves to be happier, less bothered, less self-conscious, less embarrassed, younger or less overweight after treatment with ATX-101. Statistically significant differences were achieved, at 2 mg/cm² relative to placebo, for all six individual PR-SMFIS measures (p<0.001, week 24).

ATX-101 (2 mg/cm²) also resulted in statistically significant reduction of submental fat thickness using calipers as an objective measure (p<0.05, week 24).

"These positive Phase III data build upon the strong foundation already set from previous trials, all of which have consistently demonstrated that ATX-101 is well tolerated, reduces submental fat and positively impacts patient satisfaction," said Patricia S. Walker, M.D., Ph.D., KYTHERA's Chief Medical Officer. "We are pursuing a rigorous, science-based clinical development program to support approval of ATX-101 and will continue to study the safety and efficacy of ATX-101 in our ongoing pivotal U.S. Phase III trials."