Data from RELEASE-1 and RELEASE-2 phase III studies of collagenase clostridium histolyticum

Endo International plc announced that clinical data from a Phase III investigational study of collagenase clostridium histolyticum (CCH) for the treatment of cellulite will be presented by Lawrence Bass, M.D., a board-certified plastic surgeon with a practice in New York City. Dr. Bass will present the Phase III data during the Premier Global Hot Topics session, which takes place today from 1:00pm – 6:00pm (Central Time) at the New Orleans Ernest N. Morial Convention Center. The Hot Topics session is considered to be a highlight of The Aesthetic Meeting 2019, the annual meeting of the American Society for Aesthetic Plastic Surgery (The Aesthetic Society).

The RELEASE-1 and RELEASE-2 Phase III studies, which were identically designed, randomized, double-blinded and placebo-controlled, assessed the efficacy, safety and tolerability of CCH for the treatment of cellulite in women. A greater percentage of the 843 women treated during the studies (CCH vs. placebo: RELEASE 1, n=210 vs n=213; RELEASE-2, n=214 vs n=206) met the primary endpoint of response with CCH versus placebo in both the RELEASE-1 (P=0.006) and RELEASE-2 (P=0.002) studies.In addition, statistically significant improvements with CCH versus placebo were observed for 8 of 8 (RELEASE-1) and 7 of 8 (RELEASE-2) secondary endpoints. Other patient-centric endpoints were also evaluated, including improvement in the Subject Global Aesthetic Improvement Scale (S-GAIS), a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the subject. Most adverse events observed in CCH-treated patients were mild/moderate and injection-site related (e.g., bruising, pain, nodule, pruritus, erythema, and discoloration).