Zealand Pharma A/S has announced that the last patient has been dosed in a phase II proof-of-concept, dose-finding trial with glepaglutide for the treatment of short bowel syndrome (SBS). SBS is a serious condition involving intestinal function failure following the surgical removal of large parts of the small or large intestine due to cancer, ischemia or Crohn's disease.
Patients suffering from SBS have compromised intestinal absorptive capacity and lack the ability to maintain protein-energy, fluid, electrolyte and nutrient balances on a conventional diet. Many are therefore dependent on intravenous supplements in the form of fluids, salts and nutrition delivered through a central catheter to maintain body functions.
Zealand is developing glepaglutide as a novel GLP-2 analogue, with a half-life in humans of up to 17 hours, for the treatment of SBS. Significant preclinical effects on the small and large bowels have been demonstrated, and glepaglutide was concluded to be safe and well tolerated in a phase 1 clinical trial. Glepaglutide has been designed to be stable in liquid formulations for easy and convenient daily subcutaneous dosing in an injection pen.
The primary objective of the phase II trial is to assess the effect of glepaglutide on improving patients' intestinal absorption capacity. Results from the phase II trial are expected in the summer of 2017.
"Patients with short bowel syndrome have reduced quality of life due to constant diarrhea and dependency on daily parenteral support. SBS is associated with a high risk of sepsis, blood clots, liver damage and renal impairment, so we are desperately in need of better treatment options," says Palle Jeppesen, Principal Investigator of the phase II trial and Professor MD, Department of Gastroenterology, Copenhagen University Hospital, Denmark.
In a comment about this release, Adam Steensberg, senior vice president and chief medical and development officer of Zealand, said: "We are very happy to announce that patient recruitment has been completed for the phase II dose-finding trial with glepaglutide for short bowel syndrome. Living with short bowel syndrome can be very burdensome, with some patients being dependent on intravenous infusion of liquids and nutrition for up to 16 hours per day. We are thankful for the commitment the clinical staff and patients have demonstrated in order to reach this milestone and look forward to seeing the results of the trial later this year. We are committed to bringing this product candidate through full development and hope to be able to offer this group of patients a new, convenient treatment option."
Zealand Pharma A/S is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi, Boehringer Ingelheim and Helsinn, and a pipeline of proprietary product candidates that primarily target specialty diseases with significant unmet needs.
Zealand, patient in phase ii, glepaglutide for short, bowel syndrome treatmen
