Zealand Pharma Announces Enrollment of Last Patient Needed for Interim Analysis of EASE-SBS 1 Phase 3 Trial Assessing Glepaglutide in Patients with Short Bowel Syndrome
December 16, 2021 at 02:00 am EST
Zealand Pharma A/S has enrolled the last patient required for the planned interim analysis of its pivotal Phase 3 trial (EASE-SBS 1) of glepaglutide the companys long-acting GLP-2 analog, under evaluation for the potential treatment of short bowel syndrome (SBS). The planned interim analysis, expected in Third Quarter 2022, is a result of ongoing dialogue with the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and will be conducted by an external independent Data Monitoring Committee (DMC), which will provide a recommendation to Zealand based on unblinded data. If the interim results are positive and allow for early stopping, Zealand plans to pursue a regulatory submission based on these data. The trial will remain blinded to the Company, trial investigators, and patients, to preserve the integrity of the trial. Zealand cannot disclose further details regarding the interim analysis during the remaining course of the trial.