KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced positive interim results from a Phase IIIb, multi-center, open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX-101, an investigational injectable drug for the reduction of unwanted submental fat (SMF), commonly known as double chin. The results, presented at the Late Breaking Research Symposium at the 71 st American Academy of Dermatology (AAD) Annual Meeting in Miami Beach, Fla., found that ATX-101 is well-tolerated and may be effective in reducing SMF by both clinician and patient reported outcome measures. The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101.
“In my practice, patients often request a non-surgical way to treat their submental fat, or undesirable double chin,” said investigator Susan Weinkle, MD, FAAD, a board certified dermatologist and affiliate clinical professor at the University of South Florida. “For these patients, double chin is often resistant to diet and exercise. The results of this study suggest that microinjections of ATX-101 can reduce submental fat without worsening skin laxity.”
ATX-101 is a proprietary, synthetically-derived formulation of deoxycholic acid (DCA), a naturally-occurring molecule found in the body that aids in fat metabolism. In this open-label Phase IIIb study, interim results three months after the last ATX-101 treatment found:
- Reduction of submental fat
- 87 percent of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
- Similarly, 83 percent of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
- 96 percent of patients had unchanged or improved skin laxity based on the clinician rated Submental Skin Laxity Grading Scale (SMSLG)
- 95 percent of patients were satisfied with treatment based on the Global Post Treatment Satisfaction Scale
- Adverse events were of mild to moderate intensity, transient and primarily associated with the treatment area
Topline results from this study were announced in November 2012. As previously announced, 71.3 percent of subjects had at least a one-grade improvement on the CR-SMFRS / PR-SMFRS composite and 14.0 percent had at least a two-grade improvement on the same composite measure.