- Endo International plc (NASDAQ:ENDP) has announced topline results from its Phase 2 study of collagenase clostridium histolyticum (CCH) in participants with adhesive capsulitis (AC) of the shoulder (frozen shoulder).
- While participants receiving up to three doses of CCH showed some improvement in the change from baseline in the shoulder pathology composite score, the difference compared to those study participants receiving placebo was not statistically significant.
- The safety profile of CCH in the Phase 2 study was consistent with the known safety profile from other studies.
- Most treatment-emergent adverse events were of mild to moderate severity. The most common events following treatment with CCH were injection site bruising, arthralgia, injection site pain, swelling, and contusion.
- "We are disappointed in the study outcome, and based on these data, we will be reevaluating our path forward for CCH to treat adhesive capsulitis of the shoulder," said James Tursi, Executive Vice President, Global R&D at Endo.
- The Phase 2 trial enrolled 198 participants.
- Price Action: ENDP shares are down 9.83% at $0.4199 during the premarket session on the last check Friday.
