June 11, 2012
Results from Study 17 demonstrate statistically significant reduction in submental fat (double chin) on clinician, patient and objective ratings
LOS ANGELES, June 11, 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:
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.”
Adverse events were mostly mild to moderate, and were transient. The most common adverse events were pain, swelling, numbness, bruising and redness. These adverse events were limited to the injection site; most were temporally associated with treatment. No systemic treatment-related adverse events were reported.
ATX-101-10-17 Trial Design
A total of 360 patients were randomized in Study ATX-101-10-17, a multi-center, randomized, double-blind, placebo-controlled trial conducted across 29 dermatology and plastic surgery centers in the United Kingdom, Italy, 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 and the other European Phase III trial, where ATX-101 was well tolerated and yielded statistically significant reduction of 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 component of human bile that is naturally occurring in the body and promotes the breakdown of dietary fat. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Based on clinical trials conducted to date, ATX-101 has exhibited significant, meaningful and durable results in the reduction of submental fat, which commonly presents as an undesirable “double chin.” These results correspond with patient satisfaction measures demonstrating meaningful improvement in perceived chin appearance.
In August 2010, Bayer 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 initiated its pivotal Phase III clinical program, with planned enrollment of 1,000 patients, for ATX-101 in the United States and Canada in March 2012 and expects to report results from these trials in mid-2013. These trials are expected to form the basis for a new drug application for approval of ATX-101 in the United States and Canada.
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 submental fat, which commonly presents as an undesirable “double chin.” KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring. Find more information at http://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.