March 17, 2011
Data Provides Additional Evidence of Patient Benefit on a Battery of Patient Reported Outcome Measures
LOS ANGELES, March 17, 2011 (Business Wire) – KYTHERA Biopharmaceuticals, Inc. (KYTHERA) today presented additional efficacy data from a third Phase II clinical study with ATX-101, a first-in-class adipolytic agent that is under investigation for the reduction of submental (‘under the chin’) fat. The expanded analysis focused on additional patient reported outcome measures, including instruments measuring submental fat impact, subject global assessments and subject self-ratings of chin attractiveness.
The double-blind, placebo-controlled, dose-ranging study enrolled one hundred twenty-nine subjects and was conducted across 10 dermatology and plastic surgery centers in the United States (ATX-101-09-15). Subjects received one of two dosing regimens of ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly for up to 5 months into the submental area.
Last month, KYTHERA reported and presented results from initial data analyses that showed a statistically significant clinical benefit from ATX-101 in the reduction of submental fat (SMF) as assessed by three efficacy measures: a validated clinician scale, patient reported outcome (PRO) scale, and Magnetic Resonance Imaging (MRI) measuring SMF volume. Results indicated the 2 mg/cm2 dosing regimen resulted in greater benefit, yielding statistically significantly improvements, relative to placebo, in all three efficacy measures (p<0.05, week 16 and week 32). The 1 mg/cm2 dose was associated with a smaller reduction in SMF than the 2 mg/cm2 dose, suggesting a dose-response relationship.
Results from additional patient reported outcome measures were presented today by Patricia S. Walker, MD, PhD, KYTHERA’s Chief Medical Officer, at the 35th Hawaii Dermatology Seminar™ in Maui.
Additional outcome measures include a Patient-Reported Submental Fat Impact Scale (PR-SMFIS), which was developed to assess whether subjects perceived themselves to be happier, less bothered, less self-conscious, less embarrassed, younger or less overweight after treatment with ATX-101. A statistically significant difference for the 2 mg/cm2 dose was achieved relative to placebo for all PR-SMFIS measures, as well as a composite PR-SMFIS score (p<0.05, week 32).
“These results are a testament to the psychological importance of chin appearance and definition, and the beneficial outcome resulting from treatment with ATX-101,” said Mark Rubin, MD, a dermatologist in private practice in Beverly Hills and an investigator in this study. “ATX-101 may represent a breakthrough for patients seeking submental fat reduction without surgery.”
In addition to the Patient Reported Submental Fat Impact Scale (PR-SMFIS), subjects answered global questions related to SMF. Following treatment with ATX-101 at the 2 mg/cm2 dose, compared to placebo, a statistically significantly greater proportion of subjects had improvements in: a) assessment of submental fat (p=0.001, week 32), b) definition between chin and neck (p<0.001, week 32), and c) satisfaction with ATX-101 treatment (p<0.001, week 32). Furthermore, the 2 mg/cm2 dose yielded a statistically significant difference compared to placebo in self-ratings of chin attractiveness (p<0.001, week 32).
“Patient reported outcomes are among the most important measures of success in aesthetic treatments, ” said Patricia Walker, MD, PhD. “These data suggest that a clear and meaningful effect is perceived by patients, which parallels the observed clinical effects on the physician scale and MRI assessments. We look forward to examining the benefits of ATX-101 in the context of a larger Phase III study.”
In this study, ATX-101 was well-tolerated. The most common adverse events were mild swelling, pain, numbness, bruising and induration. These adverse events were limited to the injection site, most were temporally associated with treatment and resolved within the 28-day treatment interval. No systemic treatment-related adverse events were reported.
Full results from this study will be published in an appropriate peer-reviewed journal.
ATX-101 is a first-in-class injectable drug being studied for the reduction of small volumes of fat, including submental fat. It is based on an endogenous molecule with unique features including selectivity for adipocytes and rapid clearance. This minimally invasive procedure, done with little or no anesthetic, has the promise to yield consistent and meaningful clinical results. Clinical studies to date have demonstrated that ATX-101 is well-tolerated and may effectively reduce localized fat in the submental area. Three randomized, double-blind, placebo-controlled, Phase II studies with ATX-101 in the reduction of submental fat and four Phase I studies (pharmacokinetic, histology, lipid and tolerability) have been successfully completed.
About Submental Fat (SMF)
Submental fat is localized subcutaneous fat located immediately beneath the chin and jawline. In the rapidly growing market of minimally invasive, non-surgical facial rejuvenation, the reduction of facial fat to restore and reshape the jawline remains one of the largest unmet patient needs. According to a recent national, multi-center, clinical evaluation of more than 385 BOTOX® and dermal filler patients, 78% of patients had a measurable excess of submental fat. Currently, there are no FDA approved drugs to reduce excess localized fat.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a privately held, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic market. KYTHERA has an innovative pipeline, with its lead program in adipolysis (ATX-101) projected to start US Phase III trials in 2011. The company also has active research programs in hair and fat biology, pigmentation modulation and facial contouring. Find more information at www.kytherabiopharma.com.