## Zealand Pharma Takes a Bold Step: MAA Submission for Glepaglutide
**Copenhagen, Denmark, June 2, 2025** – In a significant milestone for both patients and the medical community, Zealand Pharma A/S (Nasdaq: ZEAL) has officially submitted a **Marketing Authorization Application (MAA)** to the **European Medicines Agency (EMA)** for **glepaglutide**, a groundbreaking long-acting GLP-2 analog aimed at addressing the urgent needs of adult patients with **short bowel syndrome (SBS)**.
### A New Hope for Short Bowel Syndrome patients
The MAA submission is rooted in the promising results from the pivotal Phase 3 trial, **EASE-1**, as well as valuable insights from two ongoing long-term extension trials, **EASE-2** and **EASE-3**, alongside a mechanistic trial, **EASE-4**.
Dr. **David Kendall**, Chief Medical Officer of Zealand Pharma, expressed his enthusiasm, stating, “We are thrilled to bring our potential best-in-class GLP-2 analog, **glepaglutide**, one step closer to patients in Europe living with short bowel syndrome, who are in dire need of more effective and convenient treatment options.” He emphasized that the twice-weekly dosing regimen of glepaglutide could dramatically **reduce the reliance on parenteral support**, while alleviating the hassle of daily treatments associated with existing therapies.
### What Makes Glepaglutide Unique?
**Glepaglutide** stands out as a long-acting GLP-2 analog designed for **subcutaneous administration** using an autoinjector, delivered on a twice-weekly schedule. This innovation seeks not only to reduce the burden of parenteral support for SBS patients but also to enhance their overall quality of life. The **U.S. Food and Drug Administration (FDA)** has already granted orphan drug designation for glepaglutide, underscoring its potential significance in treating SBS.
### Understanding the EASE Clinical Trial Program
The EASE program is meticulously crafted to investigate glepaglutide’s effectiveness in minimizing or eliminating the need for parenteral support among SBS patients.
#### Highlights from EASE-1
The **EASE-1** trial (NCT03690206) enrolled 106 SBS patients who were reliant on parenteral support for at least three days a week. In this randomized, double-blind Phase 3 trial, participants were assigned to receive either **10 mg of glepaglutide** administered once or twice weekly or a placebo. The primary goal was to evaluate the absolute change in weekly parenteral support volume over 24 weeks.
The results were compelling: **glepaglutide**, when administered twice weekly, resulted in a substantial reduction of **5.13 liters/week** in parenteral support volume, a marked contrast to a reduction of just **2.85 liters/week** in the placebo group (p=0.0039). Notably, **nine** patients treated with glepaglutide were able to completely wean off parenteral support, achieving enteral autonomy, while no patients in the placebo group could do so.
### Continuing Trials: EASE-2 and Beyond
Out of the original cohort, **102 patients** completed EASE-1, with **96** continuing into the **EASE-2** extension trial, allowing for deeper insights into the drug’s safety and efficacy. Initial analyses indicate that the positive therapeutic effects associated with glepaglutide are not only sustained but continue to improve.
Following the momentum of these trials, future studies like **EASE-3** will further explore dosing options, including a weekly schedule using the autoinjector, while **EASE-4** focuses on the mechanistic implications of glepaglutide on intestinal fluid absorption.
### What Lies Ahead for Zealand Pharma?
In the latter half of 2025, Zealand Pharma is poised to initiate **EASE-5**, another Phase 3 clinical trial that will gather additional data supporting a regulatory submission in the **U.S.**. With a robust pipeline of innovative peptide-based medicines, the future looks promising for Zealand Pharma and the patients they aim to serve.
### About Zealand Pharma A/S
Founded in 1998 and headquartered in **Copenhagen, Denmark**, Zealand Pharma specializes in the discovery and development of **peptide-based medicines**. More than **10 drug candidates** have emerged from Zealand, with notable success in bringing two to market and advancing three to late-stage development. Their partnerships with various pharmaceutical companies underscore their commitment to innovation in the healthcare landscape.
For further information about Zealand Pharma’s initiatives and offerings, visit [www.zealandpharma.com](https://www.globenewswire.com/Tracker?data=uavSpH9Dp6PZrDhcQBh8Wsxs843HPSghw9wWkfwAVA9RgWH7x7Vg9qQdiiRhLMiz2WsDWunIi0UW9Vf9NgI_1x6SH3TnSWBUzWV4POq7wWk=).
### Forward-Looking Statements
This press release contains “forward-looking statements” per the Private Securities Litigation Reform Act of 1995. These statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Be cautious as you consider these projections, and rely on the scientific data presented with scrutiny.
### Get in Touch
For media inquiries or more information, please contact:
– **Adam Lange**: VP, Investor Relations – [[email protected]](mailto:[email protected])
– **Neshat Ahmadi**: Investor Relations Manager – [[email protected]](mailto:[email protected])
– **Anna Krassowska, PhD**: VP, Investor Relations & Corporate Communications – [[email protected]](mailto:[email protected])
