KYTHERA Biopharmaceuticals, Inc. (KYTHERA) presented the first results of the third phase II clinical study with ATX-101, the first official fat-dissolving substance that is currently in development for the reduction of submental fat pad. The phase IIb study showed that ATX-101 was well tolerated and had a statistically significant effect on the reduction of submental fat pad.
For the study 129 people were integrated in a double-blind, placebo-controlled and randomized dose-finding study. Implemented the treatments in 10 centers for dermatology and plastic surgery have been distributed throughout the United States. Study participants received monthly over a period of up to five months in one of two doses of ATX-101 (1 mg or 2 mg per square centimeter per square centimeter) or a placebo in the submental region. A clinical assessment of the situation was made before any treatment and four, or 12 weeks after the last treatment. An exact evaluation of the submental region by magnetic resonance imaging (MRI) was performed after pre-treatment, the fifth treatment and 12 weeks after the last treatment. In addition, the study participants had also a self-assessment using a questionnaire at the beginning, during and after the release treatment.
The data the trial showed that the regimen mg 2 per square centimeter was better in terms of the reduction of submental fat pad than when only 1 mg ATX was injected 101 per square centimeter, indicating a dose-dependent effect Close by ATX-101 can.
"The results of the study are very encouraging and demonstrate the potential of ATX-101 as an effective and well acceptable treatment plan for the aesthetic correction of small fat deposits, "said Joel Schlesinger, one of the attending physicians. "There is currently no FDA (Food and Drug Administration ) approved non-surgical method for reduction of localized fat deposits under the chin. ATX-101 could therefore be a breakthrough for patients who prefer a minimally invasive therapy for reduction of submental fat pad. "
The evaluation of the data was based on structured questionnaires, which treated both by physicians and by the Study participants were completed. In addition, the submental Region by MRI in fat content were examined.
"The results are very encouraging for us," said Patricia Walker. "We could show in three phase II studies an important and statistically significant reduction of submental fat pad. We are confident that our new data with the data from other Phase II studies will allow to take the next step in the direction phase III studies that we should then confirm definitively that ATX -101 both safe and effective. "
presented in the study was ATX-101 of the participants well tolerated. The most common side effect was mild swelling, pain, numbness, bruising and induration. Side effects were limited to the injection site and usually disappeared within the 28-day interval. Side effects that would have the rest of the body based, were not found.
addition to the results that have already been shown in Miami are, on the 35th Hawaii Dermatology Seminar ™ are presented by next March in Maui. Should also be taken together all the results and published in a journal.
About ATX-101
ATX-101 is the first official Drug that was developed exclusively for the reduction of small fat deposits. ATX-101 is based on a well-studied endogenous molecule with very specific properties, such as a high selectivity for fat cells and a rapid rate of degradation. The injection of ATX-101 is a minimally invasive procedure that requires little or no anesthesia and could still show clinically significant results. Clinical studies with ATX-101 have been able to confirm the expected results. Accordingly, ATX-101 is safe, well tolerated and effective. Three randomized, double-blind placebo-controlled phase II studies for reduction of submental fat and two phase I pharmacokinetic and histological studies have already been carried out successfully.
The submental fat is a localized fat deposits that are located directly below the chin and jaw line. In the fast-growing market for minimally invasive, non-surgical facial rejuvenation is the reduction of submental fat pad to restore a straight jawline one of the greatest unsolved problems. In a recent multicenter study with more than 385 persons for treatment with botulinum toxin or a dermal filler had imagined could be found in 78% of the sample an excess submental fat. There are currently no drugs approved by any health authorities for the reduction of localized fat .
Source: swissestetix Blog
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