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news.BioSpecifics Technologies has unveiled positive, highly statistically significant results from a phase 2b study of collagenase clostridium histolyticum (CCH) to treat cellulite, or edematous fibrosclerotic panniculopathy.
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CCH is marketed as XIAFLEX in the US and Xiapex in Europe.
BioSpecifics' partner Endo International carried out the phase 2b trial, which enrolled 375 adult women with moderate or severe cellulite aged 18 years or older.
Each subject received up to three treatment sessions of CCH (0.84 mg / session) or placebo with every treatment session taking place about 21 days apart.
Trial subjects receiving CCH demonstrated statistically significant levels of enhancement in the appearance of cellulite with treatment, as measured by the trial's primary endpoint (p<0.001), compared to those who took placebo.
The most adverse events (AEs) were mild to moderate and primarily limited to the local injection area.
92% of all related AEs were mild to moderate in the CCH group compared to 96% in the placebo group. The most common AEs were expected and included injection site bruising and injection site pain.
BioSpecifics president Thomas Wegman said: "Like in the prior Phase 2a study, 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.
"Cellulite is highly prevalent in women and we see a promising opportunity for CCH in this indication and other cosmetic indications. We look forward to our partner advancing development of CCH for cellulite into Phase 3."