Kythera reports positive results from two Phase II submental fat studies

The two Phase II, randomized, double-blind, placebo-controlled, dose-ranging studies enrolled a total of 157 patients and were conducted across 10 centers in the UK, Canada, and Australia. Multiple physician and patient endpoints were evaluated.

Study 0603 was a Phase II, randomized, double-blind, placebo-controlled, dose-ranging study which enrolled 85 patients at five centers in the UK, Canada, and Australia. This study varied drug concentrations while fixing other dosing parameters. The study endpoints included safety, tolerability, and the evaluation of efficacy as measured by both global physician assessment of submental fat, as well as patient reported outcomes.

Study 0707 was a Phase II, randomized, double-blind, placebo-controlled, dose-ranging study which enrolled 72 patients at seven centers in the UK, Canada, and Australia. Approximately five of these seven centers were distinct from Study 0603. Study 0707 varied injection spacing and volume at a fixed drug concentration. The study endpoints were identical to study 0603.

In both studies, ATX-101 was safe and tolerable and demonstrated statistically significant efficacy versus placebo. The demonstrated aesthetic correction was clinically meaningful and was matched by improvements in patient reported outcomes, the company said.

Patricia Walker, chief medical officer of Kythera, said: We are very pleased with the results and the aesthetic correction patients achieved. ATX-101 has the potential to be the first drug approved for the reduction of localized facial fat and an important tool for physicians in achieving optimal aesthetic outcomes for their patients. We look forward to presenting expanded results from these studies in a future peer-reviewed forum.