KYTHERA Biopharmaceuticals Announces Presentation of Positive Results from First of Two ATX-101 European Phase III Trials for Reduction of Submental Fat
Results from Study 16 demonstrate statistically significant reduction in submental (under the chin) fat on clinician, patient and objective ratings
LOS ANGELES--(BUSINESS WIRE)--May 7, 2012 - KYTHERA Biopharmaceuticals, Inc. (“KYTHERA”) today announced the presentation of initial trial results from Study ATX-101-10-16, the first of two pivotal European Phase III clinical trials with ATX-101, a facial injectable drug for the reduction of unwanted fat under the chin, or submental fat. V. Leroy Young, MD, FACS, presented the initial results at the American Society for Aesthetic Plastic Surgery (ASAPS) 45th Annual Aesthetic Meeting in Vancouver, British Columbia, on May 4, 2012.
The ATX-101-10-16 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 0.90 vs. 0.22; p<0.001, 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) (66.1 vs. 28.7; p<0.001, week 24).
"The positive results from this pivotal European trial demonstrate the potential of ATX-101 to be a well tolerated and effective treatment for patients who want to refine their appearance by removing fat below the chin,” said Dr. Young, a board certified plastic surgeon in private practice in St. Louis, Missouri, who is currently an investigator in the ongoing U.S. pivotal Phase III REFINE trials. “As a physician, I'm excited about the potential for ATX-101, if approved, to expand our facial injectable treatment offerings to patients looking for facial aesthetic enhancement.”
Importantly, Patient Reported Outcomes (PRO) 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 0.98 vs. 0.32; p<0.001, week 24); and
- percentage of subjects expressing satisfaction with treatment using the Global Post-Treatment Satisfaction Scale (86% vs. 45%, p<0.001, 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 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<0.001, week 24).
“These positive Phase III data are consistent with the encouraging results from previous trials, all of which have demonstrated that ATX-101 is well tolerated and provides meaningful aesthetic improvements according to multiple clinician, patient and objective measures,” said Patricia S. Walker, M.D., Ph.D., KYTHERA's Chief Medical Officer. “We have taken a rigorous scientific approach in developing and evaluating ATX-101 for the aesthetic reduction of submental fat which includes a second European Phase III trial, Study 17, and our two ongoing multi-center pivotal U.S. and Canadian Phase III trials, REFINE-1 and REFINE-2.”
Adverse events were mostly mild to moderate, and were transient. The most common adverse events were pain, swelling, numbness, bruising and induration. These adverse events were limited to the injection site; most were temporally associated with treatment. No systemic treatment-related adverse events were reported.
Results from the second pivotal European Phase III clinical trial, Study 17, will be presented at the 8th Annual Vegas Cosmetic Surgery International Multispecialty Symposium in early June.
A total of 363 patients were randomized in Study ATX-101-10-16, a multi-center, randomized, double-blind, placebo-controlled trial conducted across 28 dermatology and plastic surgery centers in the United Kingdom, France, Germany, Belgium and Spain. In this trial, patients with moderate or severe submental fat received one of two dosing regimens (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly into the submental fat area for up to four treatment visits. Clinician assessments and caliper measurements were performed at all treatment visits and 12 weeks after the last treatment visit (week 24). Subject self-assessments were performed at baseline and 12 weeks after the last treatment visit (week 24).
KYTHERA has completed substantial scientific and clinical development work on ATX-101 for the reduction of submental fat. Results from this trial are comparable to the findings already observed in previous Phase II trials, where ATX-101 was well tolerated and yielded statistically significant reduction of the unwanted submental fat compared to placebo based on the assessments of clinicians, patients and objective measurements.
ATX-101 is a potential first-in-class injectable drug candidate under clinical investigation for the reduction of localized fat. ATX-101 is a proprietary formulation of synthetic sodium deoxycholate, a well-characterized endogenous compound involved in the natural breakdown of dietary fat. ATX-101 reduces subcutaneous fat through localized fat cell membrane disruption followed by elimination from the treated area. This mechanism may enable a non-surgical alternative for the reduction of unwanted subcutaneous fat. Clinical studies to date have demonstrated that ATX-101 is well tolerated and may effectively reduce localized fat in the submental (under the chin) area.
In August 2010, Bayer Consumer Care AG signed a licensing and collaboration development agreement with KYTHERA, thereby obtaining development and commercialization rights to ATX-101 outside of the United States and Canada. KYTHERA and Bayer are collaborating on the development of ATX-101 in Europe.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. KYTHERA's product candidate, ATX-101, is a potential first-in-class, injectable treatment currently in Phase III clinical development for the reduction of fat below the chin, or submental fat. In March 2012, KYTHERA initiated a 1,000 patient pivotal Phase III clinical program for ATX-101 in the United States and Canada, to develop the compound for the North American market. The company also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring. Find more information at www.kytherabiopharma.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of more than EUR 17.2 billion (2011), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
Posted: May 2012