April 25, 2012
LOS ANGELES, April 25, 2012 – KYTHERA Biopharmaceuticals, Inc. (“KYTHERA”) and Bayer today announced the successful completion of two pivotal European Phase III clinical trials with ATX-101, an injectable drug for the reduction of unwanted fat under the chin. In a top-line analysis of the trial data, ATX-101 was well tolerated and met the pre-specified primary endpoints by demonstrating statistically significant reduction of moderate to severe submental fat, compared to placebo, as assessed by: a 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (p<0.001) and a 7-point Subject Satisfaction Rating Scale (SSRS) (p<0.001).
In addition, in both pivotal trials, ATX-101 demonstrated statistically significant efficacy compared to placebo as evaluated by secondary Patient-Reported Outcomes (PRO) (p<0.001). These improvements were also confirmed by reductions in submental fat thickness measured using calipers (p<0.025). If approved, ATX-101 will be the first in a new class of injectable drugs to reduce fat under the chin without surgery. The clinical development of ATX-101 is a joint effort of Bayer and KYTHERA.
“We are very pleased with the efficacy and patient satisfaction results of both ATX-101 European Phase III clinical trials, which showed consistent and meaningful aesthetic improvements,” said Patricia S. Walker, M.D., Ph.D., KYTHERA’s Chief Medical Officer. “An injectable solution for reduction of submental fat is an unmet need in aesthetic medicine and we look forward to continuing our development efforts with the US Phase III program.”
Data from these trials will be presented at two upcoming aesthetic meetings. The first, Study 16, will be presented at the American Society for Aesthetic Plastic Surgery (ASAPS) 45th Annual Aesthetic Meeting in early May, and the second, Study 17, will be presented at the 8th Annual Vegas Cosmetic Surgery International Multispecialty Symposium in early June.
Results from both the European Phase III trials reflect the positive 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.
“We are very encouraged by the continued positive data, which demonstrated that ATX-101 benefited patients and was also well-tolerated,” said Keith Leonard, KYTHERA’s President and CEO. “These Phase III trial findings exemplify our commitment to the discovery and development of novel science-based prescription products for the aesthetic medicine market.”
The European ATX-101 Phase III Studies
The two identical Phase III multi-center, randomized, double-blind, placebo-controlled trials enrolled 723 patients in total and were conducted in 57 centers across the United Kingdom, France, Germany, Belgium, Spain and Italy. In both trials, patients 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 cycles, and were followed up for 12 weeks post treatment. Efficacy of ATX-101 compared to placebo was assessed by a validated 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS). The Patient-Reported Outcomes (PRO) were evaluated on the basis of a 7-point Subject Satisfaction Rating Scale (SSRS), a validated 5-point Patient-Reported Submental Fat Rating Scale (PR-SMFRS) and a Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Calipers, an objective measure of submental fat thickness, also were used to assess the reduction of submental fat.
Adverse events were primarily 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. Complete data set analysis will be available in the course of 2012.
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.