Kythera Biopharmaceuticals, Inc (KYTH)

[surf1944]

9:01AM Kythera Biopharma announces additional positive efficacy and patient satisfaction data from ATX-101 Phase III trials for the reduction of submental fat (KYTH) 45.89 : Co announced additional patient satisfaction and efficacy data from REFINE-1 and REFINE-2, two pivotal Phase III clinical trials of ATX-101 for the reduction of submental fat, which commonly presents as a double chin.

The new data demonstrates that the majority of ATX-101 subjects reported satisfaction with their treatment as well as improvements on visual and psychological impacts of their "chin fat." Additionally, the vast majority of subjects had a reduction in submental fat as assessed independently by clinicians and patients, and most adverse events were transient, local to the treatment area, and mild to moderate in severity.

KYTHERA's recent REFINE-1 and REFINE-2 top line data announcement showed that both pivotal trials met all their pre-defined primary and secondary endpoints and demonstrated high statistical significance across these measures (p < 0.001). The patient satisfaction data presented at ASDS supplement the top line data and demonstrate that 88.9% of REFINE-1 and 84.2% of REFINE-2 ATX-101 treated subjects reported satisfaction with treatment received in the trial, compared to 37.7% and 43.6% of placebo subjects, respectively (p < 0.001).