The P-III (EASE 1) trial evaluating glepaglutide (10mg, qw, BIW, SC) vs PBO in ~108 patients with SBS associated with intestinal failure who were dependent on PS for 3 days/wk.
The trial met its 1EPs i.e., patients treated with glepaglutide (BIW) achieved a reduction in weekly parenteral support volume by 5.13L/wk. from baseline @24wks.; 3.13L/wk. for patients with glepaglutide (qw); 2.85L/wk. in PBO, 66% of patients in BIW had a clinical response (>20% reduction in parenteral support volume); 45.7% & 38.9% in qw & PBO treatment groups
The therapy was safe & well-tolerated, 14% were completely weaned off parenteral support in the BIW dosing group, 9 achieved enteral autonomy while no PBO-treated patients were able to discontinue parenteral support
Ref: Globenewswire| Image: Zealand Pharma
