Looking good

CHESTERBROOK, Pa.—Cellulite, a localized metabolic disorder of tissue under the skin that has been reported in 85 to 98 percent of post-pubertal women, affects all races and ethnicities. There are currently no U.S. Food and Drug Administration (FDA)-approved drug treatments available for the treatment of cellulite, and little scientific evidence that any current treatments are beneficial.

For that reason, Auxilium Pharmaceuticals Inc., a specialty biopharmaceutical company, is especially excited to announce positive results from a randomized, double-blind Phase 2a study of collagenase clostridium histolyticum (or CCH) for the treatment of edematous fibrosclerotic panniculopathy, commonly known as cellulite. According to Adrian Adams, CEO and president of Auxilium Pharmaceuticals, “Cellulite is a condition of the subcutaneous fat and skin structures that results in an ‘unappealing’ cosmetic result. The dimpling is associated with collagen tethers that pull the skin down as fat cells swell and push the skin up nearby.”

Xiaflex is the company’s currently marketed CCH product, which is designed to target and lyse, or break, those collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin. It is a biologic approved in the United States, European Union, Canada and Australia for the treatment of adult Dupuytren’s contracture (DC) patients with a palpable cord and in the United States for the treatment of adult men with Peyronie’s disease (PD) with a palpable plaque and penile curvature deformity.

Xiaflex consists of a combination of two subtypes of collagenase derived from Clostridium histolyticum. Together, the collagenase subtypes are thought to work synergistically to break the bonds of the triple-helix collagen structure. The drug has been granted Orphan Drug status in the United States by the FDA for DC and PD and is currently in Phase 2 development for cellulite and frozen shoulder syndrome.

There were 150 women between the ages of 18 and 45 enrolled in the Phase 2a study in the United States. Each of the subjects received as many as three treatment sessions of drug or placebo according to randomization, and each of the treatment sessions was approximately 21 days apart. As many as 12 injections were administered into cellulite dimples during each session across an entire treatment quadrant.

In the Phase 2a trial, all three doses of CCH (low, 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, which was adapted by the company for use as an assessment of degree of improvement in the appearance of cellulite.

The mid- and high-dose groups demonstrated a statistically significant improvement in the appearance of cellulite and reported that 68 percent of patients were “satisfied” or “very satisfied” with the results of their treatment, compared to only 34 percent of patients randomized to placebo. Other endpoints, including physician- and patient-assessed composite responder analyses, demonstrated positive and consistent results. CCH was well tolerated by all dose groups with most adverse events being mild to moderate and primarily limited to the local injection area.

Adams says that this new use for the drug in treating cellulite does not represent a departure for Auxilium, which is “a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing innovative products for specialist audiences.” He adds: “While Auxilium is committed to urology, with our core therapeutic focus and anchor position in men’s healthcare, our product portfolio and R&D pipeline is augmented by a growing therapeutic and strategic footprint in orthopedics and ongoing research in dermatology. Our current pipeline includes additional potential uses for Xiaflex (CCH) for the treatment of frozen shoulder syndrome, cellulite and human and canine lipoma. We believe that we have more experience in CCH research and development than any other company.”

 “While this condition is prevalent, it is too early to comment or speculate on the commercial opportunity. We are encouraged by Xiaflex’s track record in clinical development, and we are focused on working with the FDA to move the cellulite program into a Phase 2b clinical trial, with the anticipated start in the second quarter of 2015,” Adams concludes.