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Bile Acid Derivative Trims Fat from Double Chin

By BiotechDaily International staff writers
Posted on 14 Mar 2013
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SARTORIUS AG
An injectable drug may help patients get rid of excess submental fat (SMF) without the need for surgery, according to a new study.

Under development by Bayer Healthcare (Munich, Germany) and Kythera Biopharmaceuticals (Calabasas, CA, USA), the investigational agent ATX-101 is a synthetically-derived deoxycholic acid that prompts adipocytolysis, the permanent destruction of the fat cell. In an interim analysis of ongoing phase III trials, which enrolled 2,500 participants, in which 1,500 have been given the drug and 1,000 have received placebo, the participants reported 87% satisfaction with the results.

To assess long-term safety and efficacy, the phase IIIb study conducted at 21 sites in the US over 12 months enrolled 165 patients with moderate SMF who reported being dissatisfied with the appearance of their face and chin; 78% were female and mean age was 47. All patients had a history of stable body weight and no prior interventions to treat their double chin. All received 2 mg/cm2 of the drug by subcutaneous microinjections with a 30-gauge needle directly into preplatysmal SMF for up to six treatment sessions at 28-day intervals.

The results of the interim analysis at week 32 showed that 86.8% of patients achieved greater than a one-point improvement on the clinician-reported SMF rating scale from baseline through 12 weeks after the last treatment. Patients also reported subjective improvement, with 83% having achieved at least a one-point improvement in self-reported SMF rating scores. The treatment also received high marks for other patient-reported outcomes, including facial appearance, chin and neck definition, and unchanged or improved skin laxity. The results of the study were presented at the American Academy of Dermatology annual meeting, held during March 2013 in Miami Beach (FL, USA).

“Most patients reported feeling less self-conscious and younger, and many patients said they looked like they had lost weight even though their body mass index remained the same,” said study presenter Susan Weinkle, MD, a dermatologist in private practice in Bradenton (FL, USA). “ATX-101 appears to be well tolerated and effective at reducing submental fat, and may very well provide, in the future, an approach to submental fat for our patients who are so unhappy with this part of their body.”

Deoxycholic acid is one of the secondary bile acids secreted by the liver. It is a byproduct derived from the metabolization of chenodeoxycholic acid by intestinal bacteria. In the human body deoxycholic acid is used in the emulsification of fats for the absorption in the intestine. It has, in some countries (including Switzerland) been licensed as an emulsifier in the food industry.

Related Links:

Bayer Healthcare
Kythera Biopharmaceuticals



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