Phase 3b Results Announced for ATX-101 for Reduction of Submental Fat

Kythera Biopharmaceuticals announced positive interim results from a Phase 3b 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), also known as double chin. The results demonstrated that ATX-101 is well tolerated and may be effective in reducing SMF by both clinician and patient reported outcome measures.

This study is a multi-center, 12-month, open-label, Phase 3b 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 (2mg/cm2) by subcutaneous microinjections directly into their SMF, and were evaluated three months after their last treatment.

The interim results three months after the last ATX-101 treatment demonstrated that 87% of patients achieved at least a one-grade improvement from baseline in the reduction of submental fat on the Clinical-Reported Submental Fat Rating Scale (CR-SMFRS). Similarly, 83% of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS). Based on the clinician rated Submental Skin Laxity Grading Scale (SMSLG), 96% of patients had unchanged or improved skin laxity. Ninety five percent of patients were satisfied with treatment based on the Global Post Treatment Satisfaction scale.

ATX-101 is a potential first-in-class injectable drug candidate under clinical investigation for the reduction of unwanted submental fat. It 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.

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