NEW YORK--(BUSINESS WIRE)--KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today presented positive results that found MRI measurements of patients treated with ATX-101 demonstrated a statistically significant reduction in submental fat (SMF), commonly known as double chin, during an oral session at The Aesthetic Meeting 2013, organized by the American Society for Aesthetic Plastic Surgery (ASAPS), April 11-16, New York, NY. MRI assessments were performed in the study as a quantifiable and objective measure of submental fat volume and thickness. The same study also demonstrated positive results based on validated clinician- and patient-reported outcome measures. The results are from a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study (ATX-101-09-15) to evaluate the safety and efficacy of ATX-101, a potential first-in-class, non-surgical, injectable drug currently in Phase III clinical trials in the U.S. and Canada for the reduction of SMF.
“The MRI results of this study are exciting because they support efficacy results observed by physicians and patients from this and other clinical studies that showed a statistically significant reduction in fat under the chin with an injectable treatment,” said ATX-101 investigator, Leroy Young, M.D., FACS, a board-certified plastic surgeon in private practice in St. Louis, MO, and past president of the Aesthetic Surgery Education and Research Foundation (ASERF). “Patients also reported that the reduction in submental fat made them feel happier and less self-conscious about their appearance, which is what we strive to achieve in aesthetic medicine.”
ATX-101 is a proprietary formulation of synthetically-derived deoxycholic acid (DCA), which is an endogenous molecule that aids in the breakdown of dietary fat. Results from the Phase IIb study showed that patients treated with 2 mg/cm2 of ATX-101 demonstrated:
-
Reduction of submental fat
- Patients achieved statistically significant reduction in submental fat thickness as measured from baseline vs. placebo based on MRI (p<0.05 and p<0.001, week 16 and 32, respectively)
- Statistically significant improvement in self-evaluated visual and psychological impact of submental fat vs. placebo based on Patient-Reported Submental Fat Impact Scale (overall impact, p<0.001, week 32)
- Most adverse events were of mild to moderate intensity, transient and primarily associated with the treatment area
These results are based on a multicenter, randomized, double-blind, placebo-controlled Phase IIb study conducted at 10 sites across the U.S. The study evaluated 129 adults who received one of three dosing regimens, ATX-101 1 mg/cm2, ATX-101 2 mg/cm2, or placebo, administered as a series of microinjections into the submental area for up to six treatment visits at least 28 days apart. The study population includes males and females, aged 18-65, with moderate or severe SMF at baseline as indicated by the validated Clinician-Reported Submental Fat Rating Scale (CR-SMFRS). Subjects expressed dissatisfaction with their face and chin appearance at baseline and exhibited a stable body weight in the six months preceding the study.
“This study brings together clinician- and patient-reported outcomes on validated scales, and an objective measure to demonstrate the aesthetic improvement that results from ATX-101,” said Frederick Beddingfield, III, M.D., Ph.D., chief medical officer, KYTHERA Biopharmaceuticals, Inc. “These results, along with the strong interim results from our open-label Phase IIIb trial, support the potential of ATX-101 to enter the market as the first medical aesthetic drug approved for the reduction of submental fat.”
About ATX-101
ATX-101 is a potential first-in-class, non-surgical, injectable drug currently in Phase III clinical trials for the reduction of submental fat, which commonly presents as a “double chin.” ATX-101 is a proprietary formulation of synthetically-derived deoxycholic acid (DCA), which is an endogenous molecule that aids in the breakdown of dietary fat.
When injected into subcutaneous fat, ATX-101 physically disrupts the cell membrane of adipocytes and causes adipocytolysis, the destruction of fat cells. Adipocytolysis is followed by a natural response in which macrophages are attracted to eliminate cellular debris and lipids from the injection site. The macrophages also emit low levels of chemical messengers, known as cytokines, which attract fibroblasts, another cell type, to the area. Fibroblasts produce collagen and it is believed this results in neocollagensis. The lipid-laden macrophages are likely transported through the lymphatic system to be processed through natural physiological pathways.
Based on clinical trials conducted to date, ATX-101 has exhibited significant, meaningful and durable results in the reduction of submental fat. 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. Positive 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 U.S. and Canada in August 2012. The Company expects to release topline results in mid-2013.
ATX-101 is the first pharmacological treatment for the reduction of submental fat to be investigated under a rigorous clinical development program with the goal of seeking regulatory approvals worldwide, specifically in the U.S., Canada and Europe.
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.
Forward-Looking Statements
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 the open-label Phase IIIb study, Study ATX-101-11-26, are indicative of the final results of the study, the potential for ATX-101 to enter the market as the only FDA-approved drug for the reduction of double chin, 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 Annual Report on Form 10-K for the year ended December 31, 2012.
