Helsinn's elsiglutide misses in Phase IIb trial

Helsinn Healthcare S.A. (Lugano, Switzerland) said elsiglutide ( ZP1846) missed the primary endpoint in a Phase IIb study to prevent chemotherapy-induced diarrhea in colorectal cancer patients. The company said elsiglutide "had a positive numerical but not statistically significant effect" on the proportion of patients with diarrhea grade 2 and higher during the first cycle of chemotherapy.

Elsiglutide's safety and tolerability profile was favorable, the company said. The study's 497 patients received placebo or subcutaneous 10, 20, or 40 mg elsiglutide once daily for four days in the first two cycles of a 5-FU based chemotherapy regimen. ...