Zealand Pharma A/S (ZEAL) announced Monday that it has submitted a Marketing Authorization Application or MAA to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome or SBS.
The Danish biotechnology company focused on peptide-based medicines said the submission of the MAA was based on results of the Phase 3 program, named EASE, designed to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure.
The company further said it it expects to initiate the EASE-5 Phase 3 trial in the second half of the year to obtain further confirmatory safety and efficacy data on the twice weekly dosing regimen, supporting regulatory submission in the U.S.
Glepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for SBS. It is developed as a liquid product in an autoinjector designed for subcutaneous administration by twice weekly dosing, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS.
The U.S. Food and Drug Administration has granted orphan drug designation for glepaglutide for the treatment of SBS.
The submission of the MAA to the EMA for glepaglutide is based on results from pivotal Phase 3 trial, EASE-1, supported by interim results from two ongoing long-term extension trials and results from a mechanistic trial.
David Kendall, Chief Medical Officer of Zealand Pharma, said, "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."
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