BioSpecifics’ Xiaflex demonstrates efficacy in Phase 2a cellulite study

All CCH three doses, including a low, medium and high dose, demonstrated an improvement in the appearance of cellulite as measured by the trial endpoints of physician and patient-assessed improvements.

Conducted by BioSpecifics’ strategic partner Auxilium Pharmaceuticals, the Phase 2a study involved 150 women aged between 18 and 45, each receiving up to three treatment sessions of drug or placebo according to randomization.

Both the mid and high CCH dose groups demonstrated a statistically significant improvement in investigators’ assessments of the appearance of cellulite, as measured by the Global Aesthetic Improvement Scale (GAIS) scores.

BioSpecifics president Thomas Wegman said: "These positive results are very encouraging, particularly because both patients and physicians saw a statistically significant improvement in the appearance of cellulite after CCH treatment.

"The market for cellulite treatment is large, which makes these data very exciting for the prospective commercial success of CCH in this indication.

"The results also position CCH as a potential treatment for other aesthetic needs, so we are eager to see continued progress by Auxilium in initiating a subsequent Phase 2b trial of CCH in cellulite in the second quarter of 2015."

Marketed as Xiaflex in US and Xiapex in the European Union, CCH was well-tolerated by all dose groups with most adverse events being mild to moderate and primarily limited to the local injection area.

Also called as edematous fibrosclerotic panniculopathy, cellulite is a condition in which lobules of subcutaneous adipose tissue extend into the dermal layer, leading to loss of elasticity or shrinking of collagen cords that attach the skin to lower layers of muscle.