Zeeland Pharma A/S (NASDAQ: ZEAL) Doses First Subject in Phase 3b Study Evaluating Glepaglutide in Short Bowel Syndrome

Zeeland Pharma A/S (NASDAQ: ZEAL) has announced the dosing of the first participants in the Phase 3b study, EASE-SBS 4, assessing glepaglutide, a long-acting GLP-2 analog, that is being evaluated as a possible treatment alternative for short bowel syndrome. 

SBS has limited treatment options

The company’s EVP and Chief Medical Officer Adam Steenberg said, “SBS is a debilitating disease with limited current treatment options. We are committed to making a difference for people living with SBS and, as such, our goal with glepaglutide is to reduce the need for parenteral support so that patients can achieve nutritional goals through the course of everyday activities. This particular trial has been designed to assess the long-term direct effects of glepaglutide on intestinal fluid and energy uptake.”

The study is an open-label single-site phase 3b study evaluating glepaglutide’s long-term impact on nutritional status, administration safety, and intestinal absorption in short bowel syndrome patients. Zealand Pharma will enroll ten patients in the study who will receive 10 mg of glepaglutide through subcutaneous injection once a week for up to 25 weeks. The study is part of the company’s EASE-SBS third phase program for glepaglutide. 

Glepaglutide was developed for SBS treatment. 

Glepaglutide is a long-acting GLP-2 agonist that the company is developing for the treatment of short bowel syndrome. Notably, Zealand Pharma is developing Glepaglutide as a ready-to-use liquid medication that can be administered subcutaneously using an autoinjector for easy and convenient delivery. In October 2018, Zealand began a Phase 3 clinical trial for Glepaglutide. EASE-SBS 1 is a double-blind, randomized placebo-controlled Phase 3 trial that includes once-weekly and twice-weekly dose regimens. In addition, the US FDA has designated glepaglutide as an orphan drug for the treatment of SBS.

SBS is a severe and chronic illness characterized by a loss of intestinal function, which can be partial or complete. As a result, any patients need a connection to infusion pumps and lines on a regular basis, limiting their capacity to engage in normal activities.