Zealand Pharma Announces First Patient Dosed in EASE-SBS 4 Phase 3b Trial Assessing Glepaglutide in Patients with Short Bowel Syndrome

Zealand Pharma A/S recently announced dose administration for the first subject in the Phase 3b trial, EASE-SBS 4, evaluating glepaglutide, the company’s long-acting GLP-2 analog, which is being investigated as a potential treatment option for short bowel syndrome (SBS).

“SBS is a debilitating disease with limited current treatment options,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “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.”

EASE-SBS 4 is an open-label single-center Phase 3b trial investigating the long-term effect on intestinal absorption, nutritional status and long-term safety of administration of glepaglutide in patients with short bowel syndrome (SBS.) Ten patients will receive once weekly 10 mg subcutaneous injections of glepaglutide  over 26 weeks. This trial is part of Zealand’s EASE-SBS Phase 3 program for glepaglutide. ClinicalTrials.gov identifier (NCT number): NCT04991311.

SBS is a complex chronic and severe condition associated with reduced or complete loss of intestinal function. Many patients have to be connected to infusion lines and pumps every day, which pose significant restrictions on their ability to engage in daily activities. In addition, they are at risk of experiencing a number of serious and life-threatening complications such as sepsis, blood clots, liver damage and renal impairment.

Glepaglutide is a long-acting GLP-2 analog in development for the treatment of short bowel syndrome (SBS). Glepaglutide is being developed as a ready-to-use liquid product in an autoinjector designed for convenient and easy subcutaneous administration. Zealand initiated the Phase 3 clinical program for Glepaglutide in October 2018. The pivotal trial Phase 3 trial, EASE-SBS 1 is a randomized, double-blind and placebo-controlled study, with both once- and twice-weekly dosing regimens. The US FDA has granted orphan drug designation for glepaglutide for the treatment of SBS.

Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery, development, and commercialization of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s robust pipeline of investigational medicines includes three candidates in late-stage development. Zealand markets V-Go, a basal-bolus insulin delivery option for people with diabetes, and has received FDA approval for Zegalogue, (dasiglucagon), the first and only glucagon analogue for the treatment severe hypoglycemia in pediatric and adult patients with diabetes aged 6 and above. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide investigational agents currently in development.

Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the US that includes key locations in New York, Boston, and Marlborough (MA). For more information, visit http://www.zealandpharma.com.