Sustained Aesthetic Correction Shown in Phase 2 Study with KYTHERA ATX-101 Injectable for Submental Fat

Posted: November 13, 2011 at 4:50 pm

Kythera

KYTHERA BIOPHARMACEUTICALS Preliminary Long-Term Follow-Up Study Results from Phase 2 Trials with ATX-101

Long-Term Study Results Through 2 Years Demonstrate Sustained Aesthetic Correction by Patient and Physician Evaluation and Long-Term Tolerability of ATX-101

LOS ANGELES, November 7, 2011 (Business Wire) – KYTHERA Biopharmaceuticals, Inc. (“KYTHERA”), a privately-held biotechnology company focused on the development and commercialization of prescription products in aesthetic medicine, today presented results from a long-term follow up study assessing persistence of efficacy and post-treatment safety of ATX-101, a first-in-class, injectable drug that is under investigation for the reduction of submental (‘under the chin’) fat. Kevin C. Smith, MD, FAAD, FRCPC presented study results from the first two years of a 5-year follow up on Phase 2A patients at the 2011 Annual Meeting of the American Society for Dermatologic Surgery (ASDS) in Washington, DC.

As of mid-2011, 45 responders, defined as ATX-101 treated subjects who exhibited a 1-point improvement based on physician assessment (CR-SMFRS) at the completion of Phase 2A studies, have enrolled in the long-term follow-up study. Preliminary results demonstrate that at a 2-year follow up visit, 90% of these subjects sustained or improved their response based on physician evaluation using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS). Additionally, 80% of these subjects demonstrated sustained or improved satisfaction based on patient evaluation using the Subject Satisfaction Rating Scale (SSRS). No new adverse events were reported during the 2-year follow up evaluation period.

“These results from such a rigorously controlled study are encouraging as they address key questions in terms of long-term safety and durability of the aesthetic correction with ATX-101,” said Kevin C. Smith, a board-certified dermatologist in private practice in Niagara Falls, Ontario, Canada and an investigator in the Phase 2A and long-term follow up studies. “Treatment results with ATX-101 appear to be sustained and well-tolerated, which illustrates its potential as a novel, non-surgical approach to reducing submental fat.”

Results from two randomized, double-blind, placebo-controlled, dose-ranging Phase 2A studies were originally presented at the Scientific Session during the 2009 American Society for Dermatologic Surgery (ASDS) and American Society of Cosmetic Dermatology and Aesthetic Surgery (ASCDAS) Joint Annual Meeting. In both studies, clinical response was evaluated by physician assessment using a validated, 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and by subject assessment using a 7-point Subject Satisfaction Rating Scale (SSRS). Results demonstrated that ATX-101 was well tolerated and the most common adverse events were mild pain, swelling, numbness, bruising and induration. Additionally, ATX-101 yielded statistically significant reductions on both physician and subject assessments versus placebo in all dose groups (baseline to week 16, p<0.05).

Subjects who completed participation in the Phase 2A studies were eligible to enroll in a long-term follow-up study allowing evaluation of safety and efficacy measures for up to 5 years. Efficacy measures include physician and subject assessment using CR-SMFRS and SSRS, respectively.

“While these results are still preliminary, they support our expectation that ATX-101 may result in a long-term aesthetic correction,” said Patricia Walker, MD, PhD, KYTHERA’s Chief Medical Officer. “We look forward to continuing to follow these patients and to further characterizing the long-term safety and efficacy profile of ATX-101.”

A poster highlighting results from a Phase 2B study with ATX-101 using investigator, subject and magnetic resonance imaging assessments was also presented by Jeffrey S. Dover, MD, FRCPC, a board-certified dermatologist in private practice in Chestnut Hill, MA and an investigator in the ATX-101 Phase 2B study.

KYTHERA has completed extensive development work on ATX-101 for the reduction of submental fat, completing seven clinical trials in more than 350 subjects. European Phase 3 studies of ATX-101 were initiated in late 2010 (with completed enrollment of more than 700 subjects) in collaboration with Bayer’s Dermatology unit, which has licensed rights to ATX-101 outside of the U.S. and Canada.

About ATX-101
ATX-101 is a first-in-class injectable drug being studied for the reduction of localized fat. ATX-101 is a proprietary formulation of deoxycholate, a well-studied endogenous compound that is present in the body to promote the natural breakdown of dietary fat. ATX-101 reduces subcutaneous fat through localized fat cell membrane disruption followed by elimination from the treated area. This mechanism may enable a non-surgical alternative for the reduction of subcutaneous fat. Clinical studies to date have demonstrated that ATX-101 is well tolerated and may effectively reduce localized fat in the submental (‘under the chin’) area. Three randomized, double-blind, placebo-controlled, Phase 2 studies with ATX-101 in the reduction of submental fat and four Phase 2 studies (pharmacokinetic, histology, lipid and tolerability) have been successfully completed. Also, two Phase 3 randomized, double-blind, placebo-controlled studies are ongoing in Europe in collaboration with the Dermatology unit of Bayer, who has licensed the development and commercialization rights to ATX-101 outside of the U.S. and Canada. .

About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a privately held, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic market. KYTHERA’s lead clinical program, ATX-101, is focused on the reduction of submental (‘under the chin’) fat. The company also has active research programs with focused interest in hair and fat biology, pigmentation modulation and facial contouring. Find more information at http://www.kytherabiopharma.com.

About Bayer Dermatology
The Dermatology unit of Bayer is an integrated pharmaceutical business with its headquarters in Berlin, Germany, dedicated to offer solutions to treat skin diseases with an annual sales of EUR 300 million (2010). Bayer Dermatology is part of Bayer HealthCare and focuses on the development, manufacturing and marketing of high quality, innovative topical therapies. The current product portfolio comprises treatments of eczematous disorders including atopic dermatitis, acne, rosacea, hemorrhoidal disease and fungal skin infections (mycoses). Find out more at http://www.dermatology.bayer.com.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of more than EUR 16.9 billion (2010), 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 53,700 employees and is represented in more than 100 countries. Find more information at http://www.bayerhealthcare.com.

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