Two doses of Auxilium Pharmaceuticals’ (AUXL) already approved Xiaflex (collagenase clostridium histolyticum, or CCH) improved the appearance of cellulite in a mid-stage study, said the company on Thursday. The stock jumped 7% in early trading, though AUXL is down 50% from highs in early March. The company posted a larger-than-expected loss in the second quarter, and a new indication for Xiaflex would be a welcome addition.
Auxilium reported that two of three tested doses of CCH – 0.48mg and 0.84mg – produced a statistically significant improvement in the appearance of cellulite, measured by investigator and patient scoring on the Global Aesthetic Improvement Scale (GAIS). 68% of patients reported being “Satisfied” or “Very Satisfied” with the results, compared to only 3% of patients receiving placebo. The improvement was also statistically significant when measured by investigators. CCH was well-tolerated with mild to moderate adverse events.
The phase 2a study enrolled 150 women aged 18 and 45 in the United States. Each subject received up to three treatment sessions, 21 days apart, with up to 12 injections at each session.
Xiaflex is approved for Dupuytren’s contracture and Peyronie’s disease at 0.58 mg and generated $26.3 million in revenue in the second quarter.
Auxilium is also in the process of merging with QLT Inc (QLTI) (read more here) in order to take advantage of the Canadian company’s lower corporate tax rate.
