KYTHERA Biopharmaceuticals Announces Initiation of Pivotal U.S. Phase III Clinical Trials to Evaluate ATX-101 for Reduction of Submental Fat

REFINE trials will investigate the efficacy, safety and tolerability of ATX-101, a first-in-class, injectable drug candidate under clinical investigation for the reduction of fat under the chin.

LOS ANGELES, CA, USA I March 5, 2012 I KYTHERA Biopharmaceuticals, Inc. (KYTHERA), a privately-held biotechnology company focused on the development and commercialization of prescription products in aesthetic medicine, today announced the initiation of two pivotal U.S. Phase III trials of ATX-101, a first-in-class injectable drug under clinical investigation for the reduction of submental (under the chin) fat.

The Phase III trials, known as REFINE-1 and REFINE-2 (Randomized Double-blind Evaluation of Submental Fat Reduction IN ATX-101 TrEated Patients), are the first pivotal prospective, placebo-controlled trials of an injectable fat reduction agent under an active U.S. registration program.

“The design for the REFINE trials is based on multiple prior pre-clinical and clinical trials, which to date have shown encouraging efficacy and safety data for ATX-101,” said Patricia S. Walker, M.D., Ph.D., KYTHERA’s Chief Medical Officer. “We hope these Phase III trials, as part of our continued clinical investigation of ATX-101, will ultimately lead to a safe, effective and well-studied treatment for the reduction of unwanted submental fat.”

Trial Design

The two multi-center, randomized, double-blind, placebo-controlled, Phase III trials will assess the efficacy, safety and tolerability of ATX-101 (2 mg/cm2) subcutaneous injections versus placebo for the reduction of localized subcutaneous fat in the submental area as measured from baseline to 12 weeks after final treatment. The trials will be conducted in approximately 70 centers across the U.S. and Canada and will enroll a total of 1,000 patients, randomized (1:1) to ATX-101 or placebo.

The Phase III trials will measure efficacy using two independent scales – the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and the Patient-Reported Submental Fat Rating Scale (PR-SMFRS). These scales were developed and validated by KYTHERA and used successfully in the previously reported 129-patient Phase IIB study of ATX-101. The two scales will be used as a composite to define a responder as a patient who simultaneously achieves a pre-defined threshold of change on both the clinician-reported and patient-reported measures.

Secondary endpoints will measure the reduction in volume of submental fat using Magnetic Resonance Imaging (MRI) in a subset of subjects at selected centers, and improvement in both appearance and psychological related impacts of submental fat as assessed with a Patient-Reported Submental Fat Impact Scale (PR-SMFIS).

“The initiation of our pivotal REFINE-1 and REFINE-2 clinical trials marks meaningful progress as we continue to assess the efficacy and safety of ATX-101 as a non-surgical alternative for localized fat reduction,” said Keith Leonard, KYTHERA’s President and CEO. “We see a large unmet need for a safe, effective and clinically-proven treatment for patients who seek cosmetic procedures with high aesthetic value that don’t require surgery. We are focused on continued rigorous testing to validate the potential of ATX-101 as a first-in-class injectable drug for those who want to reduce fat under their chin without surgery.”

KYTHERA has completed substantial development work on ATX-101 for the reduction of submental fat. In previous studies, ATX-101 was well-tolerated and yielded statistically significant reduction of submental fat compared to placebo based on clinician, patient and MRI assessments. Additionally, preliminary results from the first two years of an ongoing five-year, non-treatment follow-up study demonstrate that more than 90 percent of patients enrolled in the long-term study maintained or improved their response.

In addition, two European Phase III trials of ATX-101 were initiated in late 2010 in collaboration with Bayer Dermatology, which has exclusively licensed rights to ATX-101 outside of the U.S. and Canada. Top-line results from these European Phase III trials are expected in the first half of 2012.

About ATX-101

ATX-101 is a first-in-class injectable drug candidate under clinical investigation for the reduction of localized fat. ATX-101 is a proprietary formulation of sodium 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 II studies with ATX-101 for the reduction of submental fat and four Phase I studies (pharmacokinetic, histology, lipid and tolerability) have been successfully completed. Also, two Phase III randomized, double-blind, placebo-controlled studies are ongoing in Europe in collaboration with Bayer Dermatology, which 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 www.kytherabiopharma.com.

About Bayer Dermatology

The Dermatology unit of Bayer is an integrated pharmaceutical business with its headquarters in Berlin, Germany, dedicated to offering solutions to treat skin diseases, with an annual sales of EUR 316 million (2011). 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 www.dermatology.bayer.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 Pharmaceuticals

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