Clinical Trials

Date: 2017-02-06

Type of information: Completion of patient enrollment

phase: 2

Announcement: completion of patient treatment

Company: Zealand Pharma (Denmark)

Product: glepaglutide (ZP1848)

Action mechanism:

• peptide/glucagon-like peptide-2 (GLP-2) receptor agonist/GLP2 analogue. ZP1848 is a long-acting, stable and soluble GLP-2 receptor agonist invented and wholly owned by Zealand Pharma.  In preclinical studies, ZP1848 has shown to significantly increase small intestine mass compared to a marketed GLP-2 analogue. Glepaglutide has a half-life in humans of up to 17 hours. 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.

Disease: short bowel syndrome

Therapeutic area: Rare diseases - Gastrointestinal diseases

Country: Denmark

Trial details: The study is a proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with short bowel syndrome. (NCT02690025)

Latest news:

•  • On February 6, 2017, Zealand Pharma announces 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. This disease is a rare 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 short bowel syndrome 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. 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.
• • On February 15, 2016, Zealand Pharma announced  that it has successfully dosed the first patients in a clinical Phase II Proof-of-Concept trial with ZP1848 for the treatment of short bowel syndrome (SBS). GLP-2 based therapy is an established concept in the treatment of SBS, and in preclinical studies, ZP1848 has shown promising effects over existing treatment. The start of patient in the Phase II trial is an important step in the further development of ZP1848 in that the trial is intended to demonstrate the clinical relevance and profile of the product as a new and better treatment option. The Phase II Proof-of-Concept trial with ZP1848 is a randomized, double-blind, dose-finding trial to investigate the clinical efficacy and safety of the compound in the treatment of SBS. The trial is conducted at the world-leading gastrointestinal center at the University Hospital of Copenhagen (Rigshospitalet), Denmark, and will enroll 18 patients with SBS. Patients in the trial will be randomized to three dosis groups and treated with two different doses of ZP1848 for a total of six weeks interrupted by a wash-out period. The primary objective of the trial is to assess the effect of ZP1848 on improving patients’ intestinal absorption capacity measured as reduction in fecal wet weight output. In addition, the trial will evaluate a number of relevant secondary efficacy endpoints, including change in urine weight and changes in absorption of electrolytes and macronutrients. Completion of and results from the Phase II trial are expected in 2017.
• • On September 17, 2015, Zealand Pharma announced the initiation of a clinical Phase II development program for its proprietary peptide therapeutic, ZP1848, for the treatment of Short Bowel Syndrome (SBS). In preclinical studies, ZP1848 has shown efficacy on small intestine growth and demonstrated the physico-chemical properties of a long-acting, stable and soluble peptide therapeutic with the potential for convenient administration in liquid formulation. Zealand has also investigated ZP1848 in a combined single (SAD) and multiple (MAD) ascending dose Phase I trial. Results from this trial demonstrated that ZP1848 is safe and well tolerated with a supportive effect on bowel function. The attractive potential identified for ZP1848 in Short Bowel Syndrome and the opportunity for Zealand to initiate a clinical Phase II development program in this specialist care indication is an important step in line with the company\'s strategic focus on increasing the value of its proprietary pipeline. The Phase II Proof-of-Concept trial is planned as a randomized, double-blind, dose-finding trial to investigate the clinical efficacy and safety of ZP1848 in patients with SBS. The primary objective of the trial will be to assess intestinal absorption. The first patients are planned to be enrolled and dosed in Q1 2016.

Is general: Yes