These results are based on a multicenter, 12-month, open-label Phase IIIb study conducted at 21 sites across the United States, evaluating 165 adults who received injections of ATX-101 for up to six treatments at four-week intervals. Patients received ATX-101 (2 mg/cm 2) 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, an industry standard scale to categorize skin tone, are represented.
“We are pleased with these ATX-101 study results,” said Patricia S. Walker, M.D., Ph.D., chief medical officer, KYTHERA Biopharmaceuticals, Inc. “These results, along with efficacy analyses in double-blind, placebo-controlled studies, support ATX-101 entering the market as potentially the first medical aesthetic drug approved for the reduction of submental fat.”
ATX-101 is a potential first-in-class injectable drug candidate under clinical investigation for the reduction of unwanted submental fat. ATX-101 is a proprietary formulation of synthetic deoxycholic acid, a well-characterized endogenous compound that is present in the body to promote the natural breakdown of dietary fat. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Based on clinical trials conducted to date, ATX-101 has exhibited significant, meaningful and durable results in the reduction of submental fat, which commonly presents as an undesirable “double chin.” 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. 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.