MIAMI BEACH, Fla.--(BUSINESS WIRE)--KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced four abstracts will be presented at the 71st American Academy of Dermatology (AAD) Annual Meeting in Miami Beach, Fla. The abstracts, including one to be presented at the Late Breaking Research Symposium on March 2, evaluate the safety, efficacy and pharmacokinetics of ATX-101, an investigational injectable drug being studied for the nonsurgical reduction of submental fat (SMF), commonly known as the double chin. The ATX-101 global clinical development program has enrolled more than 2,500 total patients of which more than 1,500 have been treated with ATX-101.
The abstracts include:
- ATX-101 (deoxycholic acid injection) for the reduction of submental fat: Interim results from a multicenter, 12-month, open-label study (Late Breaking Research Symposium)
- ATX-101 for the reduction of double chin caused by submental fat: Results from the ATX-101-10-16 European phase III study (Poster: P6257, available March 1)
- Reduction of double chin caused by submental fat with ATX-101: Results from the ATX-101-10-17 European phase III study (Poster: P6256, available March 1)
- Open-label pharmacokinetic study to evaluate lipid levels in the blood following injections of ATX-101 (deoxycholic acid) (Poster: P5917, available March 1)
“KYTHERA Biopharmaceuticals is at the forefront of addressing the unmet need for a safe, clinically proven injectable drug for the reduction of undesirable submental fat,” said Keith Leonard, president and chief executive officer, KYTHERA Biopharmaceuticals, Inc. “The data being presented this week further supports the scientific and clinical rigor of the ATX-101 development program. We look forward to the final results of our Phase III trials and potentially entering the market with this important first-in-class aesthetic drug.”
The complete abstracts can be found in the April 2013 supplement to the Journal of the American Academy of Dermatology (JAAD), volume 68, number 4.
About ATX-101
ATX-101 is a potential first-in-class injectable drug candidate under clinical investigation for the reduction of unwanted submental fat. ATX-101 is a proprietary formulation of synthetic deoxycholic acid, a well-characterized endogenous compound that is present in the body to promote the natural 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 subject 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 U.S. and Canada. Bayer recently completed two pivotal Phase III trials of ATX-101 in Europe for the reduction of submental fat. Topline results from these trials were reported in the second quarter of 2012. KYTHERA completed enrollment in its pivotal Phase III clinical program for ATX-101 in more than 1,000 subjects, randomized to ATX-101 or placebo, in 70 centers across the United States and Canada in August 2012. The Company expects to release topline results in mid-2013.
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 initiated its pivotal Phase III clinical program for ATX-101 in March 2012, and completed enrollment of more than 1,000 patients, randomized to ATX-101 or placebo, in 70 centers across the U.S. and Canada in August 2012. KYTHERA also maintains an active research interest in hair and fat biology. Find more information at www.kytherabiopharma.com.
To the extent that statements contained in this press release are not descriptions of historical facts regarding KYTHERA, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including the potential for KYTHERA to enter the market with ATX-101. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, the regulatory approval process, the development progress of our collaborative partners, our substantial dependence on ATX-101 and other matters that could affect the availability or commercial potential of our drug candidate. KYTHERA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see KYTHERA’s reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012.