Kythera Biopharmaceuticals, Inc (KYTH)

[surf1944]

1:32AM Kythera Biopharma provides positive interim results from open-label study of ATX-101 in the reduction of unwanted submental fat (KYTH) 25.12 : Co announces positive interim results from a Phase IIIb, multi-center, open-label study to evaluate the safety and efficacy of ATX-101, an investigational injectable drug 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. The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101. In this open-label Phase IIIb study, interim results three months after the last ATX-101 treatment found:

Reduction of submental fat o 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
95%of patients were satisfied with treatment based on the Global Post Treatment Satisfaction Scale
Adverse events were of mild to moderate intensity, transient and primarily associated with the treatment area