LOS ANGELES, Jun 11, 2012 (BUSINESS WIRE) –
KYTHERA
Biopharmaceuticals, Inc. (“KYTHERA”) today announced the
presentation of initial trial results from Study ATX-101-10-17, the
second of two pivotal European Phase III clinical trials with ATX-101,
a facial injectable drug for the aesthetic treatment of submental fat,
which commonly presents as an undesirable double chin. Ashish Bhatia,
MD, presented the results at the 8th Annual Vegas Cosmetic Surgery
International Multispecialty Symposium in Las Vegas, Nevada, on June 10,
2012.
The ATX-101-10-17 trial met its pre-specified primary endpoints based on
clinician and patient assessments. At the 2 mg/cm(2) dose,
ATX-101 resulted in a statistically significant reduction of submental
fat, relative to placebo, as measured using a 5-point Clinician-Reported
Submental Fat Rating Scale (CR-SMFRS) (mean of 0.77 vs. 0.36; p
“As a physician, I’m enthusiastic about the potential for an ‘in-office’
facial injectable treatment to reduce our patients’ double chins, an
issue of increasing concern for our patients, but not easily or
effectively treated today,” said Dr. Bhatia, a board certified
dermatologist and Assistant Professor of Clinical Dermatology at
Northwestern University Feinberg School of Medicine, Chicago, IL, who is
currently an investigator in the ongoing U.S. pivotal Phase III REFINE
trials. “The results from this pivotal European trial are a positive
signal in the development of this new injectable for the reduction of
submental fat.”
Importantly, other Patient Reported Outcomes specific to treatment with
ATX-101 (2 mg/cm(2)) also resulted in statistically significant
differences, relative to placebo, in the:
–
reduction of submental fat using a 5-point Patient-Reported Submental
Fat Rating Scale (PR-SMFRS) (mean of 0.94 vs. 0.41; p
–
percentage of subjects expressing satisfaction with treatment using
the Global Post-Treatment Satisfaction Scale (84.8% vs. 58.1%, p
Additional Patient Reported Outcomes included a Patient-Reported
Submental Fat Impact Scale (PR-SMFIS), which was developed to measure
the visual and psychological impacts of submental fat, including whether
patients perceived themselves to be happier, less bothered, less
self-conscious, less embarrassed, younger or less overweight after
treatment with ATX-101. Statistically significant differences were
achieved, at 2 mg/cm(2) relative to placebo, for all six
individual PR-SMFIS measures (p
ATX-101 (2 mg/cm(2)) also resulted in statistically significant
reduction of submental fat thickness using calipers as an objective
measure (p
“These positive Phase III data build upon the strong foundation already
set from previous trials, all of which have consistently demonstrated
that ATX-101 is well tolerated, reduces submental fat and positively
impacts patient satisfaction,” said Patricia S. Walker, M.D., Ph.D.,
KYTHERA’s Chief Medical Officer. “We are pursuing a rigorous,
science-based clinical development program to support approval of
ATX-101 and will continue to study the safety and efficacy of ATX-101 in
our ongoing pivotal U.S. Phase III trials.”
Adverse events were mostly mild to moderate, and were transient. The
most common adverse events were pain, swelling, numbness, bruising and
redness. These adverse events were limited to the injection site; most
were temporally associated with treatment. No systemic treatment-related
adverse events were reported.
ATX-101-10-17 Trial Design
A total of 360 patients were randomized in Study ATX-101-10-17, a
multi-center, randomized, double-blind, placebo-controlled trial
conducted across 29 dermatology and plastic surgery centers in the
United Kingdom, Italy, France, Germany, Belgium and Spain. In this
trial, patients with moderate or severe submental fat received one of
two dosing regimens (1 mg/cm(2) or 2 mg/cm(2)) or
placebo, administered monthly into the submental fat area for up to four
treatment visits. Clinician assessments and caliper measurements were
performed at all treatment visits and 12 weeks after the last treatment
visit (week 24). Subject self-assessments were performed at baseline and
12 weeks after the last treatment visit (week 24).
KYTHERA has completed substantial scientific and clinical development
work on ATX-101 for the reduction of submental fat. Results from this
trial are comparable to the findings already observed in previous Phase
II trials and the other European Phase III trial, where ATX-101 was well
tolerated and yielded statistically significant reduction of unwanted
submental fat compared to placebo based on the assessments of
clinicians, patients and objective measurements.
About ATX-101
ATX-101 is a potential first-in-class injectable drug candidate under
clinical investigation for the reduction of localized fat. ATX-101 is a
proprietary formulation of synthetic sodium deoxycholate, a
well-characterized component of human bile that is naturally occurring
in the body and promotes the breakdown of dietary fat. ATX-101 is
designed to be a locally-injected drug that causes proximal,
preferential destruction of adipocytes, or fat cells, with minimal
effect on surrounding tissue. Based on clinical trials conducted to
date, ATX-101 has exhibited significant, meaningful and durable results
in the reduction of submental fat, which commonly presents as an
undesirable “double chin.” These results correspond with patient
satisfaction measures demonstrating meaningful improvement in perceived
chin appearance.
In August 2010, Bayer signed a licensing and collaboration development
agreement with KYTHERA, thereby obtaining development and
commercialization rights to ATX-101 outside of the United States and
Canada. KYTHERA initiated its pivotal Phase III clinical program, with
planned enrollment of 1,000 patients, for ATX-101 in the United States
and Canada in March 2012 and expects to report results from these trials
in mid-2013. These trials are expected to form the basis for a new drug
application for approval of ATX-101 in the United States and Canada.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company focused on the discovery, development and commercialization of
novel prescription products for the aesthetic medicine market. KYTHERA’s
product candidate, ATX-101, is a potential first-in-class, injectable
treatment currently in Phase III clinical development for the reduction
of submental fat, which commonly presents as an undesirable “double
chin.” KYTHERA also maintains an active research interest in hair and
fat biology, pigmentation modulation and facial contouring. Find more
information at
http://www.kytherabiopharma.com .
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the
fields of healthcare, nutrition and high-tech materials. Bayer
HealthCare, a subgroup of Bayer AG with annual sales of more than EUR
17.2 billion (2011), is one of the world’s leading, innovative companies
in the healthcare and medical products industry and is based in
Leverkusen, Germany. The company combines the global activities of the
Animal Health, Consumer Care, Medical Care and Pharmaceuticals
divisions. Bayer HealthCare’s aim is to discover and manufacture
products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 55,700 employees and is represented
in more than 100 countries. Find more information at
www.bayerhealthcare.com .
SOURCE: KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc.
Media Contact:
Erica Bazerkanian, 805-300-9289
ebazerkanian@kytherabiopharma.com
or
Investor Contact:
Heather Rowe, 818-587-4559
hrowe@kytherabiopharma.com
Copyright Business Wire 2012
