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surf1944

04/08/13 10:26 AM

#11 RE: surf1944 #5

1:34AM Kythera Biopharma reports positive interim results from open-label Phase IIIb study of ATX-101 (KYTH) 20.35 : Co reports positive interim results from a Phase IIIb, multicenter, evaluating the safety and efficacy of ATX-101, a potential first-in-class, non-surgical, injectable drug in Phase III trials for the reduction of unwanted submental fat, commonly known as "double chin." The results found that ATX-101 is well tolerated and may be effective in reducing SMF by both clinician- and patient-reported outcome measures.

Observations were made using validated rating instruments for which one-grade changes are considered to be clinically meaningful:

Reduction of submental fat:
87% of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale
Similarly, 83% of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale
96% of patients had unchanged or improved skin laxity based on the clinician rated Submental Skin Laxity Grading Scale
97% of patients reported improvement in chin and neck definition
Adverse events were primarily of mild to moderate intensity, transient and associated with the treatment area