January 6, 2009
LOS ANGELES, January 6, 2009 – KYTHERA Biopharmaceuticals, Inc. (KYTHERA) today announced that it has successfully completed two Phase 2 clinical studies demonstrating the efficacy, safety, and tolerability of its lead product candidate, ATX- 101, for the reduction of submental (‘under-the-chin’) fat. The two Phase 2, randomized, double-blind, placebo-controlled, dose-ranging studies enrolled a total of 157 patients and were conducted across 10 centers in the United Kingdom, Canada, and Australia. Multiple physician and patient endpoints were evaluated.
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.
“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,” said Patricia Walker, MD, PhD, KYTHERA’s Chief Medical Officer. “We look forward to presenting expanded results from these studies in a future peer- reviewed forum.”
Study Designs Study 0603 was a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study which, enrolled 85 patients at five centers in the United Kingdom, 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 (on a validated aesthetic scale), as well as patient reported outcomes.
Study 0707 was a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study which, enrolled 72 patients at seven centers in the United Kingdom, Canada, and Australia. 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.
ATX-101 is a first-in-class injectable product being studied for the reduction of small volumes of fat. ATX-101 clinical research is focused on treating localized facial fat deposits, including submental fat. KYTHERA has completed two international randomized, double-blind, placebo-controlled, Phase 2 studies with ATX-101 in the treatment of submental fat as well as a U.S. Phase 1 pharmacokinetic study.
About Submental Fat (SMF)
Submental fat is a localized subcutaneous fat deposit located immediately beneath the chin and jawline. In the rapidly growing market of minimally-invasive, non-surgical facial rejuvenation, the reduction of facial fat deposits to restore and reshape the jawline remains one of the largest unmet patient needs. According to a recent national, multi- center, clinical evaluation of more than 220 BOTOX® and dermal filler patients, 73% of patients had excessive submental fat.