Endo's CCH successful in late-stage cellulite studies, but response levels modest; shares down 7% [Seeking Alpha]
Endo International plc - Ordinary Shares (ENDP)
Last endo international plc - ordinary shares earnings: 2/26 06:00 am
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Source: Seeking Alpha
Results from two identical Phase 3 clinical trials, RELEASE 1 & 2 , evaluating Endo International's ( ENDP ) collagenase clostridium histolyticum (CCH) for the treatment of cellulite showed a treatment benefit. Each study met the primary endpoint of at least a two-point composite improvement in cellulite severity in the target buttock at day 71 compared to placebo. Specifically, 7.6% of subjects in RELEASE-1 and 5.6% in RELEASE-2 achieved statistically significant improvements in cellulite compared to 1.9% and 0.5%, respectively, for control. The separations were statistically valid, but the response rates appear lower than expected. Seven of eight key secondary endpoints were also met. On the safety front, CCH was well-tolerated with most adverse events being mild or moderate, primarily involving injection site reactions. CCH, a combination of bacterial enzymes that break down collagen, is marketed in the U.S. by Endo's pharmaceutical unit as XIAFLEX fo
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