Zealand Pharma completes enrollment in EASE-SBS 1 phase III trial assessing glepaglutide in patients with short bowel syndrome.
Glepaglutide is being investigated for once or twice weekly administration with an autoinjector and has received Orphan Drug Designation by the 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 II meeting with the 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.
With completion of patient enrollment into EASE-SBS 1, the EASE-SBS 2 extension trial has been amended to allow for direct enrollment without prior participation in EASE-SBS 1. The EASE-SBS 2 trial is a two-year Phase IIIb trial assessing safety and efficacy of glepaglutide dosed once and twice weekly. In this long term safety study, there is no placebo arm.
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