MONTE CARLO, Monaco--(BUSINESS WIRE)-- <\/p>\n
KYTHERA Biopharmaceuticals, Inc. (KYTH) today announced positive interim results from a Phase IIIb, multicenter, open-label study (ATX-101-11-26) of ATX-101 during the Innovations and Renewals session of the 11th Anti-Aging Medicine World Congress (AMWC), April 4-6, Monte Carlo, Monaco. The study, presented by investigator Susan Weinkle, MD, FAAD, evaluated the safety and efficacy of ATX-101, a potential first-in-class, non-surgical, injectable drug in Phase III trials for the reduction of unwanted submental fat (SMF), commonly known as double chin. The results found that ATX-101 is well tolerated and may be effective in reducing SMF by both clinician- and patient-reported outcome measures. AMWC is the worlds largest event for global aging management, and attracts aesthetic dermatologists, surgeons and clinicians in the regenerative, preventative and anti-aging medicine industry from more than 95 countries. <\/p>\n
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. <\/p>\n
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: <\/p>\n
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. <\/p>\n
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. <\/p>\n
We are encouraged by the interim Phase IIIb results of ATX-101, said Frederick Beddingfield, III, M.D., Ph.D., KYTHERAs 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. <\/p>\n
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. <\/p>\n
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. <\/p>\n
About ATX-101 <\/p>\n
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Link: MONTE CARLO, Monaco--(BUSINESS WIRE)-- KYTHERA Biopharmaceuticals, Inc. (KYTH) today announced positive interim results from a Phase IIIb, multicenter, open-label study (ATX-101-11-26) of ATX-101 during the Innovations and Renewals session of the 11th Anti-Aging Medicine World Congress (AMWC), April 4-6, Monte Carlo, Monaco Continue reading
\nKYTHERA Biopharmaceuticals, Inc. Announces Positive Interim Results from Open-Label Phase IIIb Study of ATX-101 at the ...<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"