The primary objective of the trial is to characterize the pharmacokinetic profile of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects.
Press Release- No. 11/2017
Recruitment completed in trial to evaluate the optimal dosing frequency for Zealand’s long-acting GLP-2 analog glepaglutide
- All 75 subjects dosed with glepaglutide in the clinical trial
- The trial was initiated based on positive Phase 2 results reported in June 2017 in patients with short bowel syndrome
- Results from the trial are expected in Q1 2018
Copenhagen, Denmark, November 14, 2017 - Zealand Pharma announces that all subjects have been enrolled and dosed in a clinical trial with glepaglutide under an investigational new drug application (IND) for the treatment of short bowel syndrome (SBS). Following positive results from a Phase 2 trial in June 2017 indicating a longer than expected half-life for glepaglutide, Zealand initiated the ongoing pharmacokinetic (PK) trial to investigate the potential for less than once-daily dosing. 75 subjects have been enrolled in the trial.
The primary objective of the trial is to characterize the pharmacokinetic profile of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects (ClinicalTrials.gov identifier: NCT03279302). Results from the trial are expected in Q1 2018.
Adam Steensberg, Executive Vice President, Chief Development and Medical Officer of Zealand, comments: “We look forward to the results of this trial, which explores the potential for less frequent dosing of glepaglutide. The results will guide the design of our Phase 3 study for treatment of short bowel syndrome and with the fast recruitment into this trial, we remain on track to initiate the Phase 3 glepaglutide program in 2018.”
In June 2017, Zealand reported positive results from the Phase 2 trial of glepaglutide in adult patients with short bowel syndrome (SBS). The aim of the trial was to assess the efficacy, safety and tolerability of different doses of glepaglutide. Glepaglutide successfully met the primary study endpoint of reducing fecal wet weight output. In addition, glepaglutide increased energy absorption, and the pharmacokinetic data confirmed the long half-life of glepaglutide when dosed daily. Detailed data from the trial will be presented at the ASPEN conference on January 23, 2018 in Las Vegas.
Short bowel syndrome (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 bodily functions.
For further information, please contact:
Britt Meelby Jensen, President and CEO
Tel.: +45 51 67 61 28, e-mail: bmj@zealandpharma.com
Mats Blom, Executive Vice President and Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: mabl@zealandpharma.com
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) 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 and Boehringer Ingelheim as well as a pipeline of internal product candidates focusing on specialty gastrointestinal and metabolic diseases.
Zealand is based in Copenhagen, Denmark. For further information about the Company’s business and activities, please visit www.zealandpharma.com or follow us on Twitter @ZealandPharma or LinkedIn.
