Auxilium Pharma Reports Positive Data From Phase 2a Trial Of CCH For Cellulite

(RTTNews) - Auxilium Pharmaceuticals, Inc. (AUXL), a specialty biopharmaceutical company, announced positive results from a randomized, double-blind Phase 2a trial of collagenase clostridium histolyticum or CCH for edematous fibrosclerotic panniculopathy or EFP, commonly known as cellulite.

In the Phase 2a trial, all three doses of CCH, mid and high showed an improvement in the appearance of cellulite as measured by the trial endpoints of an investigator and a patient score on the Global Aesthetic Improvement Scale or GAIS, which was adapted by the firm for use in cellulite. The mid and high dose groups showed a statistically significant improvement in the appearance of cellulite, as measured by GAIS scores, with a p-value of <0.05 compared to placebo for both endpoints.

In the mid and high dose groups, 68 percent of patients reported being "Satisfied" or "Very Satisfied" with the results of their treatment, compared to only 34 percent of patients randomized to placebo. Positive and consistent results were also demonstrated across the trial's other endpoints, including Physician and Patient assessed Composite Responder Analyses. CCH was well-tolerated by all dose groups with most adverse events being mild to moderate and primarily limited to the local injection area.

Chief Executive and President of Auxilium Pharmaceuticals stated: "We believe these data establish proof-of-concept for CCH as a potential treatment for cellulite and enable Auxilium to pursue our development and regulatory strategy to most efficiently and effectively advance this exciting program. We look forward to initiating a planned Phase 2b clinical trial in the second quarter of 2015."

The Phase 2a trial enrolled 150 women between the ages of 18 and 45 in the U.S.