Kythera Biopharmaceuticals Announces Positive Interim Results From Open-Label P3 Study of ATX-101
Published: Apr 08, 2013
“The positive interim results are consistent with previous ATX-101 studies,” said Weinkle, a board certified dermatologist and affiliate clinical professor at the University of South Florida, Tampa, Fla., U.S. “Worldwide, doctors are receiving requests from their patients for a non-surgical way to treat their double chin. The results of this study suggest that microinjections of ATX-101 have an acceptable safety profile and can reduce the appearance of a double chin with high patient satisfaction.”
ATX-101 is a proprietary formulation of synthetically-derived deoxycholic acid (DCA), a molecule found in the body that helps break down dietary fat. In this open-label Phase IIIb study, interim results three months after the last ATX-101 treatment are outlined below. Observations were made using validated rating instruments for which one-grade changes are considered to be clinically meaningful:
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)
97 percent of patients reported improvement in chin and neck definition
Adverse events were primarily of mild to moderate intensity, transient and associated with the treatment area
As previously announced, 71.3 percent of subjects had at least a one-grade improvement on the CR-SMFRS / PR-SMFRS composite and 14.0 percent had at least a two-grade improvement on the same composite measure.
These results are based on a multicenter, 12-month, open-label, Phase IIIb study conducted at 21 sites across the U.S., evaluating 165 adults who received injections of ATX-101 for up to six treatments at four-week intervals. Patients received ATX-101 (2 mg/cm2) 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 are represented.
“We are encouraged by the interim Phase IIIb results of ATX-101,” said Frederick Beddingfield, III, M.D., Ph.D., KYTHERA’s chief medical officer. “The results, along with additional data from our ATX-101 clinical development program, support the potential for ATX-101 to enter the market as the only U.S. Food and Drug Administration (FDA)-approved drug for the reduction of double chin.”
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. When injected, ATX-101 targets the fat cells, or adipocytes, and destroys and eliminates them.
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.
ATX-101 is a potential first-in-class, non-surgical, injectable drug 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), a molecule found in the body that helps break down dietary fat.
When injected, ATX-101 targets the fat cells and destroys them. The destruction of the fat cells is followed by a natural response that results in the submental fat being eliminated from the treatment area, and it is believed that the treatment results in neocollagensis at the treatment site. The fat that is cleared from the body is transported through the lymphatic system, which is similar to how the body processes dietary fat.
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 United States 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.
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, 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.
KYTHERA Biopharmaceuticals, Inc.
Associate Director, Investor Relations
Tel: (818) 587- 4559