Press Release - No. 14/2018
Zealand Pharma to present new clinical Phase 2 results on glepaglutide for the treatment of short bowel syndrome at the DDW conference in the U.S.
- The results demonstrates glepaglutide's effects on intestinal transit time, morphology and energy absorption
- Supports the primary results of the trial, which demonstrated reductions in diarrhea/fecal output and increases in intestinal wet weight absorption
- Zealand remains on track to initiate the pivotal Phase 3 trial, with weekly and twice-weekly dosing of glepaglutide, in H2 2018
Copenhagen, May 31, 2018 - Zealand Pharma ("Zealand"), announces that Rahim M. Naimi, MD and Mark Hvistendahl, MSc in clinical nutrition, both Department of Gastroenterology, Rigshospitalet, University of Copenhagen, Denmark, will present new results from the Phase 2 trial for the treatment of short bowel syndrome at the annual Digestive Disease Week (DDW) meeting June 2-5, 2018 in Washington, DC, U.S. The abstracts has been published on the DDW website.
The DDW conference is the world's largest gathering of medical professionals in the specialties of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. The three abstracts are:
- Mark Hvistendahl et al.: Glepaglutide, a Glucagon-like Peptide-2 Analog, Ameliorates Accelerated Gastrointestinal Transit Time in Patients with Short Bowel Syndrome.
Poster presentation session on June 3rd, 2018 (Abstract No. 2897919)
- Rahim M. Naimi et al.: Effects of Short-term Treatment with Glepaglutide, a Long-acting Glucagonlike pepide-2-analog, on Intestinal Morphology and Citrulline in Patients with Short Bowel Syndrome.
Oral presentation on June 4th, 2018 (Abstract No. 2904756)
- Mark Hvistendahl et al.: Glepaglutide, a Long-acting Glucagon-like Peptide-2 analog, Improves Intestinal Absorption of Macronutrients, Body Weight and Lean Body Mass in Patients with Short Bowel Syndrome.
Oral presentation on June 5th, 2018 (Abstract No. 2888499)
Adam Steensberg, Executive President and Chief Medical and Development Officer of Zealand comments: "We are very pleased with the comprehensive results from the glepaglutide Phase 2 trial and the progress towards offering patients with short bowel syndrome a new potential once-weekly convenient treatment opportunity. The new clinical Phase 2 results presented at the DDW conference are encouraging, and we look forward to soon start the Phase 3 confirmatory trial."
The Phase 2 trial was conducted in collaboration with investigator Prof. Palle B Jeppesen and team at
Rigshospitalet, University of Copenhagen, Denmark, one of the world's leading centers for the treatment of SBS. The trial was a 3-week proof-of-concept, double-blind, cross-over, dose-finding trial investigating the efficacy and safety of three different doses of glepaglutide (0.1 mg, 1 mg and 10 mg per day). Following, positive End-of-Phase 2 interactions with the US FDA and EU EMA, Zealand remains on track for initiating the pivotal Phase 3 trial in H2 2018. The 26-week trial will enroll approximately 130 patients with short bowel syndrome to test efficacy and safety of once- and twice weekly dosing with glepaglutide over placebo.
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About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a late-stage clinical portfolio of proprietary product candidates focusing on specialty gastrointestinal and metabolic diseases. In addition, it has two marketed products, commercialized by Sanofi, and two product candidates under license collaboration with Boehringer Ingelheim.
Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.