Zealand Pharma Presents Data at 2021 ESPEN Virtual Congress Demonstrating Dose-dependent Effects of Glepaglutide in Both Small and Large Intestines of Animal Models – in Contrast to Short-acting GLP-2
Zealand Pharma (Nasdaq: ZEAL) presented data at the 2021 ESPEN Virtual Congress demonstrating the dose-dependent effects of glepaglutide in treating short bowel syndrome (SBS). The company showcased four posters, including a Poster of Distinction, emphasizing the drug's potential advantages over short-acting GLP-2 analogs. Glepaglutide is currently in Phase 3 clinical trials and has received orphan drug designation from the FDA. The findings reinforce glepaglutide's pharmacokinetic profile and its dosing regimen's efficacy.
- Glepaglutide is currently in Phase 3 clinical trials for treating short bowel syndrome (SBS).
- Data presented at ESPEN include a Poster of Distinction, indicating potential differentiation from short-acting GLP-2.
- FDA granted orphan drug designation for glepaglutide, enhancing its development prospects.
- None.
Company announcement – No. 59/ 2021
Zealand Pharma Presents Data at 2021 ESPEN Virtual Congress Demonstrating Dose-dependent Effects of Glepaglutide in Both Small and Large Intestines of Animal Models – in Contrast to Short-acting GLP-2
- Presentations at the 2021 European Society for Clinical Nutrition and Metabolism (ESPEN) Virtual Congress include a Poster of Distinction comparing glepaglutide to short-acting GLP-2
- Two additional glepaglutide posters detail PK and PD profiles following once weekly dosing in healthy subjects and subjects with varying degrees of renal function
Copenhagen, DK and Boston, MA, U.S. September 9, 2021 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, today announced it will present four posters at the 2021 European Society for Clinical Nutrition and Metabolism (ESPEN) Virtual Congress, which is being held September 9-14, 2021. The Company’s research presented at ESPEN 2021 will feature multiple posters, including one Poster of Distinction, related to glepaglutide for the treatment of short bowel syndrome (SBS).
“We are excited about the clinical progress of glepaglutide, currently in Phase 3 clinical trials for the treatment of SBS, and we are proud to present new research on the program at ESPEN 2021,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “SBS is a debilitating condition where parenteral support is often needed for patient survival. The data presented at ESPEN demonstrate the attractive profile of glepaglutide following once-weekly dosing in humans and the dose-dependent effects on both small and large intestines in animals, underscoring its differentiation as a potential treatment option for SBS.”
| Poster Title: Acute intestinotrophic effects of short and long-acting GLP-2 analogues in rat |
| Author: J. Skarbaliene and M. Berner-Hansen |
| Poster Viewing Reception Date and Time: September 9-14, 2021 |
| Abstract Number: PD-26 |
| Poster Title: Pharmacokinetics and pharmacodynamics of long-acting GLP-2 analogue glepaglutide after once-weekly dosing in adult healthy subjects |
| Author: K. Sonne, K. Mark Knudsen, J. Mosolff Mathiesen, M. Berner-Hansen, G. Koefoed Rasmussen |
| Poster Viewing Reception Date and Time: September 9-14, 2021 |
| Abstract Number: P239 |
| Poster Title: Glepaglutide pharmacokinetic profile after single subcutaneous injection in human subjects with varying degrees of renal function |
| Author: M. Askjær Agersnap, K. Sonne, K. Mark Knudsen, S. Wladyslaw |
| Poster Viewing Reception Date and Time: September 9-14, 2021 |
| Abstract Number: P234 |
| Poster Title: Geographic Evolution of Pediatric Intestinal Failure (pIF) Management in the United States (US) |
| Author: D. Mercer, K. Iyer, D. Pfeffer, L. Brøsted Zimmerman, M. Berner-Hansern, M. Mundi, D.L. Seidner |
| Poster Viewing Reception Date and Time: September 9-14, 2021 |
| Abstract Number: P099 |
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.
About Glepaglutide
Glepaglutide is a long-acting GLP-2 analog in development for the treatment of short bowel syndrome (SBS). Glepaglutide is being developed as a ready-to-use liquid product in an autoinjector designed for convenient and easy subcutaneous administration. Zealand initiated the Phase 3 clinical program for Glepaglutide in October 2018. The pivotal trial Phase 3 trial, EASE-SBS 1 is a randomized, double-blind and placebo-controlled study, with both once- and twice-weekly dosing regimens. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, development, and commercialization of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. Zealand markets V-Go®, a basal-bolus insulin delivery option for people with diabetes, and Zegalogue®, (dasiglucagon), the first and only glucagon analogue for the treatment severe hypoglycemia in pediatric and adult patients with diabetes aged 6 and above. To support these two marketed products Zealand built a dedicated sales force in the United States and has established itself as a fully integrated biotechnology company. In addition, license collaborations with Boehringer Ingelheim and AstraZeneca create opportunities for more patients to potentially benefit from Zealand-invented peptide investigational agents currently in development.
Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit http://www.zealandpharma.com.
Forward-Looking Statement
This press release contains “forward-looking statements”, as that terms is defined in the Private Securities Litigation Reform Act of 1995, as amended, that provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release and are based on information available to Zealand Pharma as of the date of this release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.
For further information, please contact:
| Zealand Pharma Investor Relations |
| Claudia Styslinger |
| Argot Partners |
| investors@zealandpharma.com |
| Zealand Pharma Media Relations |
| David Rosen |
| Argot Partners |
| media@zealandpharma.com |
FAQ
What data did Zealand Pharma present regarding glepaglutide at the 2021 ESPEN Congress?
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