Zealand blindsided by FDA rejection of glepaglutide

Denmark’s Zealand Pharma (Nasdaq: ZEAL) has been hit with a complete response letter (CRL) from the US regulator for glepaglutide, a long-acting GLP-2 analog.

The therapy, which is being developed to treat short bowel syndrome in patients reliant on parenteral support, must now be put through a new Phase III trial to confirm efficacy and safety.

The Danish biotech’s submission relied on data from the Phase III EASE-1 trial, which evaluated glepaglutide in both once-weekly and twice-weekly dosing regimens. While the twice-weekly dose fared well, the once-weekly dose failed to achieve statistical significance.