KYTHERA,
announced the presentation of initial trial results from Study
ATX-101-10-16, the first of two pivotal European Phase III clinical
trials with
ATX-101 (a first-in-class injectable drug being studied for the reduction of
localized fat. ATX-101 is a proprietary formulation of deoxycholate (see below structure) a
well-studied endogenous compound that is present in the body), a facial injectable drug for the reduction of unwanted
fat under the chin, or submental fat. V. Leroy Young, MD, FACS,
presented the initial results at the American Society for Aesthetic
Plastic Surgery (ASAPS) 45th Annual Aesthetic Meeting in
Vancouver, British Columbia, on May 4, 2012.
The ATX-101-10-16 trial met its pre-specified primary endpoints
based on clinician and patient assessments. At the 2
mg/cm2 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 0.90 vs. 0.22; p<0.001, week 24).
Similarly, ATX-101 (2 mg/cm2) resulted in a
statistically significant percentage of subjects, relative to
placebo, achieving a pre-defined categorical change using a 7-point
Subject Self Rating Scale (SSRS) (66.1 vs. 28.7; p<0.001, week
24).
"The positive results from this pivotal European trial demonstrate the potential of ATX-101 to be a well tolerated and effective treatment for patients who want to refine their appearance by removing fat below the chin,” said Dr. Young, a board certified plastic surgeon in private practice in St. Louis, Missouri, who is currently an investigator in the ongoing U.S. pivotal Phase III REFINE trials. “As a physician, I'm excited about the potential for ATX-101, if approved, to expand our facial injectable treatment offerings to patients looking for facial aesthetic enhancement.”
Importantly, Patient Reported Outcomes (PRO) specific to
treatment with ATX-101 (2 mg/cm2) 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 0.98 vs. 0.32; p<0.001, week 24); and
- percentage of subjects expressing satisfaction with treatment using the Global Post-Treatment Satisfaction Scale (86% vs. 45%, p<0.001, week 24).
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/cm2 relative to
placebo, for all PR-SMFIS measures (p<0.001, week 24).
ATX-101 (2 mg/cm2) also resulted in statistically
significant reduction of submental fat thickness using calipers as
an objective measure (p<0.001, week 24).
“These positive Phase III data are consistent with the
encouraging results from previous trials, all of which have
demonstrated that ATX-101 is well tolerated and provides meaningful
aesthetic improvements according to multiple clinician, patient and
objective measures,” said Patricia S. Walker, M.D., Ph.D.,
KYTHERA's Chief Medical Officer. “We have taken a rigorous
scientific approach in developing and evaluating ATX-101 for the
aesthetic reduction of submental fat which includes a second
European Phase III trial, Study 17, and our two ongoing
multi-center pivotal U.S. and Canadian Phase III trials, REFINE-1
and REFINE-2.”
Adverse events were mostly mild to moderate, and were transient.
The most common adverse events were pain, swelling, numbness,
bruising and induration. These adverse events were limited to the
injection site; most were temporally associated with treatment. No
systemic treatment-related adverse events were reported.
Ref : http://www.kytherabiopharma.com/newsroom/
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