Press release – No. 10 / 2019
Zealand Pharma enrolls first patient in Phase 3 extension study of glepaglutide for treatment for short bowel syndrome
- The Phase 3 extension trial will evaluate long-term safety and efficacy of glepaglutide and enrolls short bowel syndrome (SBS) patients that have completed the pivotal Phase 3 trial.
- The pivotal Phase 3 registration trial with glepaglutide for the treatment of SBS remains on track with results expected in 2020.
- Glepaglutide is a long-acting GLP-2 analog with potential for once-weekly dosing in an auto-injector pen.
Copenhagen, May 7, 2019 – Zealand Pharma A/S (“Zealand”) (ZEAL) (CVR-no. 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, has enrolled the first patient in a Phase 3 extension trial to evaluate the long-term safety and efficacy of glepaglutide treatment in patients with short bowel syndrome (SBS).
Patients who have completed either of the preceding Phase 2 and Phase 3 trials for glepaglutide as treatment for SBS may be eligible to participate in the Phase 3 extension trial. Safety and efficacy will be evaluated throughout a two-year duration.
“We are focused on improving the lives of people living with short bowel syndrome, and this extended trial demonstrates our commitment to delivering better treatment options for SBS,” said Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma. “We are grateful for the SBS patients that participate in our clinical studies. It’s our intention that this extension trial will help patients continue their pursuit of better health outcomes by improving intestinal absorption with glepaglutide.”
“Transitioning SBS patients into the glepaglutide extension trial is a positive advancement. We interpret it as a sign of good study conduct as well as good tolerability of the product,” added Adam Steensberg, Executive Vice President and Chief Medical and Development Officer at Zealand Pharma.
Additional details about the Phase 3 extension trial of glepaglutide to treat SBS can be found on ClinicalTrials.gov.
For further information, please contact:
Emmanuel Dulac, President and Chief Executive Officer
Tel.: +45 50 60 36 36, e-mail: firstname.lastname@example.org
Lani Pollworth Morvan, Investor Relations and Communication
Tel.: +45 50 60 37 78, e-mail: email@example.com
About short bowel syndrome (SBS)
SBS is a complex chronic and severe condition associated with reduced or complete loss of intestinal function. Many patients have to be connected to infusion lines and pumps every day, which pose significant restrictions on their ability to engage in daily activities. In addition, they are at risk of experiencing a number of serious and life-threatening complications such as sepsis, blood clots, liver damage and renal impairment.
Glepagtluide is a long-acting GLP-2 analog being developed in an auto-injector with potential for convenient weekly administration as treatment for short bowel syndrome (SBS). Zealand Pharma aspires to provide the next generation, best-in-class therapies to help transform the lives of people living with SBS. Glepaglutide has the potential to be a best-in-class GLP-2 therapy, allowing people with SBS a fast, reliable and well-tolerated treatment option to reduce dependence on parenteral support.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Zealand’s portfolio also includes two clinical license collaborations with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals.
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.