Phase III study of ATX 101 (Kythera Biopharmaceuticals) shows treatment helps reduce submental fat

Kythera Biopharmaceuticals has 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 (sodium deoxycholate) for the reduction of unwanted submental fat commonly known as double chin. Results show that 87 percent of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale. Similarly 83 percent of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS).

Ninety six percent of patients had unchanged or improved skin laxity based on the clinician rated Submental Skin Laxity Grading Scale and 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. These latest results presented at the 71st American Academy of Dermatology (AAD) Annual Meeting.