KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced positive interim results from a Phase IIIb, multi-center, open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX-101, an investigational injectable drug for the reduction of unwanted submental fat (SMF), commonly known as double chin. The results, presented at the Late Breaking Research Symposium at the 71 st American Academy of Dermatology (AAD) Annual Meeting in Miami Beach, Fla., found that ATX-101 is well-tolerated and may be effective in reducing SMF by both clinician and patient reported outcome measures. 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. “In my practice, patients often request a non-surgical way to treat their submental fat, or undesirable double chin,” said investigator Susan Weinkle, MD, FAAD, a board certified dermatologist and affiliate clinical professor at the University of South Florida. “For these patients, double chin is often resistant to diet and exercise. The results of this study suggest that microinjections of ATX-101 can reduce submental fat without worsening skin laxity.” ATX-101 is a proprietary, synthetically-derived formulation of deoxycholic acid (DCA), a naturally-occurring molecule found in the body that aids in fat metabolism. In this open-label Phase IIIb study, interim results three months after the last ATX-101 treatment found:
- Reduction of submental fat
- 87 percent of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
- Similarly, 83 percent of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
- 96 percent of patients had unchanged or improved skin laxity based on the clinician rated Submental Skin Laxity Grading Scale (SMSLG)
- 95 percent of patients were satisfied with treatment based on the Global Post Treatment Satisfaction Scale
- Adverse events were of mild to moderate intensity, transient and primarily associated with the treatment area
These results are based on a multicenter, 12-month, open-label Phase IIIb study conducted at 21 sites across the United States, evaluating 165 adults who received injections of ATX-101 for up to six treatments at four-week intervals. Patients received ATX-101 (2 mg/cm 2) by subcutaneous microinjections directly into their SMF, and were evaluated three months after their last treatment. The study population includes females (77.6 percent) and males (22.4 percent) with a mean age of 47, who report at least moderate SMF and dissatisfaction with the appearance of their chin. All Fitzpatrick Skin Types, an industry standard scale to categorize skin tone, are represented.“We are pleased with these ATX-101 study results,” said Patricia S. Walker, M.D., Ph.D., chief medical officer, KYTHERA Biopharmaceuticals, Inc. “These results, along with efficacy analyses in double-blind, placebo-controlled studies, support ATX-101 entering the market as potentially the first medical aesthetic drug approved for the reduction of submental fat.” 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: that the interim results of Study ATX-101-11-26 are indicative of the final results of the study and the potential for ATX-101 entering the market as the first medical aesthetic drug approved for the reduction of submental fat and our expectations regarding the timing of reporting data from our ongoing U.S. and Canadian Phase III clinical trials of 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.