KYTHERA presents additional data from third ATX-101 Phase II clinical study in submental fat reduction

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.

“These results are a testament to the psychological importance of chin appearance and definition, and the beneficial outcome resulting from treatment with ATX-101”

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 35^th 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>2 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.