KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced four abstracts will be presented at the 71 st 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.