Zealand Pharma A/S announced completion of patient enrollment in its pivotal Phase 3 trial (EASE-SBS 1) of glepaglutide, the company's long-acting GLP-2 analog, for the potential treatment of short bowel syndrome (SBS). Glepaglutide is being investigated for once or twice weekly administration with an autoinjector and has received Orphan Drug Designation by the U.S. FDA. The trial sample size has been reduced to approximately 108 patients from the original sample size of 129 patients to mitigate expected recruitment challenges caused by the renewed COVID outbreak.

The trial will have 95% power (versus the original 98%) to detect a treatment effect on the primary endpoint. Due to the current plan, extent of patient roll-over into long-term extension trials, and prolonged follow-up caused by COVID disruptions, the cumulative exposure to glepaglutide at the time of the potential NDA submission will be larger than originally anticipated at the End of Phase 2 meeting with the U.S. FDA. Full results of the trial are expected in the third quarter of 2022 as a result of increased recruitment over the recent months.

The previously announced interim analysis is therefore no longer required, preserving statistical power for the full analysis.