Auxilium Pharmaceuticals announced positive results from a Phase IIa study of collagenase clostridium histolyticum (or CCH) for the treatment of cellulite, or edematous fibrosclerotic panniculopathy. According to the firm, all three doses of CCH (low [0.06 mg], mid [0.48 mg], and high [0.84 mg]) improved the appearance of cellulite as measured by the trial endpoints of an investigator and a patient score on an adapted version of the Global Aesthetic Improvement Scale (GAIS).
The mid- and high-dose groups in particular showed a statistically significant improvement in the appearance of cellulite, with a p-value of <0.05 compared to placebo for both endpoints. Sixty-eight percent of patients in those groups reported being "satisfied" or "very satisfied" with the results of their treatment, compared to only 34 percent of patients on placebo. Auxilium says the trial's other endpoints, including physician and patient-assessed composite responder analyses, also showed positive and consistent results.
Auxilium's CEO and president Adrian Adams said in a statement that the firm finds these results very encouraging. "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," he added. The company is planning to initiate a Phase IIb trial in the second quarter of 2015.
CCH, also known as Xiaflex®, is approved in the U.S., EU, Canada, and Australia for the treatment of adult Dupuytren's contracture patients with a palpable cord. It is also approved in the U.S. for the treatment of adult men with Peyronie's disease with a palpable plaque and penile curvature deformity of at least 30 degrees at the start of therapy.