Zealand Pharma submits glepaglutide MAA for short bowel syndrome

Glepaglutide is intended for administering two times a week for SBS.

The application is based on results from the pivotal Phase III clinical trial EASE-1, supported by interim data from current long-term extension trials (EASE-2 and EASE-3) and outcomes from the EASE-4 trial.

The US Food and Drug Administration (FDA) has awarded orphan drug designation to glepaglutide, currently under development as a potential treatment for SBS.

Glepaglutide is developed as a liquid therapy, for administration subcutaneously using an autoinjector. The treatment aims to reduce the need for parenteral support (PS) in individuals affected by SBS.

The randomised, double-blind Phase III EASE-1 trial involved 106 SBS patients who were dependent on PS. Patients received either 10mg of glepaglutide administered once or twice weekly or placebo. Further 102 out of the total participants completed the trial, with 96 continuing into ongoing long-term EASE-2.

EASE-2 continues evaluating the safety and efficacy as participants maintain their assigned treatments from EASE-I.

Patients completing EASE-2 are eligible to participate in EASE-3. Interim results from this trial indicate that reductions in prescribed PS have been generally sustained among initial participants transitioning from EASE-2.

Furthermore, the Phase IIIb trial EASE-4 investigated mechanistic effects related to intestinal fluid and energy uptake due to glepaglutide treatment. The outcomes suggest pharmacodynamic benefits associated with improved intestinal absorption capabilities linked to this therapy.

Zealand Pharma chief medical officer David Kendall said: “We are pleased to bring our potential best-in-class GLP-2 analogue, glepaglutide, one step closer to patients in Europe living with short bowel syndrome with intestinal failure, who urgently need more effective and more convenient treatment options.”

“We believe that glepaglutide, administered twice weekly, offers meaningful potential to reduce both the burden of parenteral support and the inconvenience of daily dosing required with the only currently available GLP-2 therapy.”