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Re: surf1944 post# 11

Monday, 04/15/2013 8:27:42 AM

Monday, April 15, 2013 8:27:42 AM

Post# of 39
12:53AM Kythera Biopharma presents positive MRI results from Phase IIb study of ATX-101 in the Reduction of Submental Fat or 'Double Chin' (KYTH) 22.46 : Co presents positive results that found MRI measurements of patients treated with ATX-101 demonstrated a statistically significant reduction in submental fat, commonly known as double chin. MRI assessments were performed in the study as a quantifiable and objective measure of submental fat volume and thickness. The same study also demonstrated positive results based on validated clinician- and patient-reported outcome measures.

Results from the Phase IIb study showed that patients treated with 2 mg/cm2 of ATX-101 demonstrated:

Reduction of submental fat o Patients achieved statistically significant reduction in submental fat thickness as measured from baseline vs. placebo based on MRI (week 16 and 32, respectively)
Statistically significant improvement in self-evaluated visual and psychological impact of submental fat vs. placebo based on Patient-Reported Submental Fat Impact Scale (overall impact, week 32)
Most adverse events were of mild to moderate intensity, transient and primarily associated with the treatment area