Kythera's lead candidate appears to reduce chin fat in Phase II
This article was originally published in Scrip
Kythera Biopharmaceuticals' lead product candidate, ATX-101, appeared to have been successful in reducing submental (under-the-chin) fat in two Phase II trials.
According to the Los Angeles-based company, ATX-101 is a first-in-class injectable product for the removal of localised facial fat deposits.
"We are very pleased with the results and the aesthetic correction patients achieved. ATX-101 has the potential to be the first drug approved for the reduction of localised facial fat and an important tool for physicians in achieving optimal aesthetic outcomes for their patients," said Dr Patricia Walker, the company's chief medical officer.
Kythera said that it would make plans for Phase III trials after it has finished analysing the Phase II data. Additionally, the company plans to market the product itself in the US, and is considering its licensing to other companies to market it around the rest of the world.
Both studies, known as 0603 and 0707, were randomised, double-blind, placebo-controlled and dose-ranging, with study endpoints of safety, tolerability, and the evaluation of efficacy as measured by a physician assessment and by patient reported outcomes.
Study 0603 enrolled 85 patients and studied the drug at various concentrations. Study 0707 enrolled 72 patients and assessed injection spacing and volume at a fixed concentration.
Submental fat is a localised subcutaneous fat deposit located beneath the chin and jaw line. Kythera claims that patients suffering from the condition represent one of the largest unmet needs in the rapidly expanding market of non-surgical facial rejuvenation.