Sep 4 2012
KYTHERA Biopharmaceuticals, Inc. (KYTHERA) today announced the completion of
enrollment in two pivotal U.S. and Canadian Phase III clinical trials of ATX-101,
a potential first-in-class injectable facial aesthetic drug under
clinical investigation for the reduction of submental fat, which
commonly presents as an undesirable "double chin." KYTHERA expects to
release top-line results in mid-2013.
"We are pleased to achieve another significant corporate milestone as
part of our global development program for ATX-101," said Keith Leonard,
KYTHERA's President and CEO. "We look forward to continued clinical
development of ATX-101 as part of our corporate commitment to develop
first-in-class, prescription products that address unmet needs for the
aesthetic physician and patient communities."
The U.S. and Canadian Phase III trials, known as REFINE-1 and REFINE-2 (Randomized
Double-blind Evaluation of Submental Fat Reduction IN
ATX-101 TrEated Patients) enrolled more than 1,000 patients,
randomized (1:1, or a sample size of 250 patients per arm, per trial) to
ATX-101 or placebo, in 70 centers across the U.S. and Canada. KYTHERA
and Bayer, KYTHERA's collaborator outside the United States and Canada,
announced positive results from two pivotal Phase III trials of ATX-101
in Europe in the second quarter of 2012. These clinical trials
demonstrated that ATX-101 was well tolerated and met the pre-specified
primary endpoints by demonstrating statistically significant reduction
in submental fat, which corresponded with patient satisfaction measures
demonstrating meaningful improvement in self-perception related to the
appearance of their chin fat.
Source: KYTHERA Biopharmaceuticals, Inc.