KYTHERA Biopharmaceuticals, Inc. (KYTHERA) today presented detailed results from two double-blind Phase 2 studies, each designed to evaluate the safety and effectiveness of ATX-101, a first-in-class injectable drug for the reduction of small volumes of fat. Top-line results from these studies, which examined use of ATX-101 for reduction of unwanted localized fat deposits under the chin (submental fat), were announced in January 2009.
Kevin C. Smith MD, FAAD, FRCPC presented study results in Scientific Session at the American Society for Dermatologic Surgery (ASDS) and American Society of Cosmetic Dermatology and Aesthetic Surgery (ASCDAS) Joint Annual Meeting. A recap of the data presentation will be available online at http://www.kytherabiopharma.com/investors.html for seven days.
“ATX-101 shows promise for patients who are seeking a minimally invasive treatment for unwanted localized submental fat,” said Kevin C. Smith, a Canadian investigator in both Phase 2 studies. “The significant reduction we saw in submental fat for patients treated with ATX-101 illustrates its potential as a safe, simple prescription aesthetic product.”
In total, one hundred fifty-seven subjects were randomized in two double-blind, placebo-controlled, dose-ranging studies conducted across 10 centers in the United Kingdom, Canada and Australia. Across these studies, subjects received one of five dosing regimens of ATX-101 or placebo; one dosing regimen was duplicated between studies.
In each study analyzed independently, two of the three dosing regimens tested yielded a statistically significant reduction of unwanted submental fat compared to placebo as measured by physician assessment (ATX-101-06-03 both p<0.05, and ATX-101-07-07 both p<0.01). Submental fat was evaluated at baseline and week 16, using a 5-point Submental Fat Rating Scale.
Similarly, subject self-assessment indicates that treatment with ATX-101 yielded statistically significant improvement in three of three (ATX-101-06-03, all p<0.05) and two of three (ATX-101-07-07, both p<0.01) dosing regimens versus placebo. Subjects were asked to rate appearance at baseline and week 16, using a 7-point Subject Satisfaction Rating Scale.