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Zealand Pharma Announces Multiple Presentations at the 82nd Annual American Diabetes Association Scientific Sessions, Including Initial Clinical Data on GLP-1/GLP-2 Dual Agonist Dapiglutide

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Zealand Pharma
Zealand Pharma

PRESS RELEASE – NO. 1 / 2022

Zealand Pharma Announces Multiple Presentations at the 82nd Annual American Diabetes Association Scientific Sessions, Including Initial Clinical Data on GLP-1/GLP-2 Dual Agonist Dapiglutide

  • A total of five presentations with Zealand Pharma products have been accepted for presentation at the American Diabetes Association (ADA)

  • Abstracts include oral presentation of data from a Phase 1 Multiple Ascending Dose Trial with dapiglutide

  • Data highlight and reinforce the Company’s commitment to advancing research and development of new treatment options for the management of diabetes and obesity

Copenhagen, DK and Boston, MA, U.S. May 31, 2022 Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that three oral presentations and two poster abstracts with Zealand Pharma products have been accepted for the upcoming 82nd Scientific Sessions of the American Diabetes Association (ADA), which is being held in New Orleans from June 3-7, 2022.

Zealand Pharma has two oral presentations, including Phase 1 clinical data demonstrating significant weight loss with Zealand’s dapiglutide, a novel GLP1/GLP2 dual agonist and preclinical data on the antidiabetic potential of the company’s long-acting amylin analogue ZP8396. Zealand also has a poster presentation with preclinical data highlighting the weight loss effects of ZP8396.

Two additional abstracts include study results from a Zealand supported, investigator-initiated trial (IIT) with dasiglucagon led by investigators from the Steno Diabetes Center. This oral presentation reports novel data on the use of low dose dasiglucagon for prevention and treatment of non-severe hypoglycemia in people with type 1 diabetes. Additionally, Boehringer Ingelheim will have a poster presentation with preclinical data on the dual glucagon and glucagon-like peptide-1 receptor (GCGR/GLP-1R) agonist BI 456906 co-invented with Zealand Pharma, for the treatment of obesity.

ZEALAND PHARMA PRESENTATION DETAILS

Oral Presentation Title: Dapiglutide, a Once-Weekly GLP-1R/GLP-2R Dual Agonist, Was Safe and Well Tolerated and Showed Dose-Dependent Body Weight Loss over Four Weeks in Healthy Subjects
Session Title: Incretin Based Therapies
Presenting Author: Mikkel Agersnap MD, Medical Director – Clinical Development

Presentation Date and Time: Monday, June 6th 5:00 - 5:15 PM (CDT)
Session Location: Hall E-2 (Level 1)
Abstract Number: 335-OR

Oral Presentation Title: Antidiabetic Potential of Novel, Long-Acting Amylin Analogue ZP8396 in ZDF Rats
Session Title: Lipids, Lipoproteins, and Diabetes (With ADA Presidents' Select Abstract Presentation)
Presenting Author: Jolanta Skarbaliene, PhD, Principal Scientist – Clinical Pharmacology

Presentation Date and Time: Sunday, June 5th , 2022, 6:00 - 6:15 PM (CDT)
Location: 356 (Level 3)

Abstract Number: 213-OR

Poster Title: ZP8396, a Novel Amylin Analogue, Induces Weight Loss in DIO Rats with a Formulation Space at Physiological pH
Author: Jolanta Skarbaliene, PhD, Principal Scientist – In vivo Pharmacology

Poster Viewing Reception Date and Time: Monday, June 6th , 2022 12:00 – 1:00 PM (CDT)
Location: Hall D-E
Abstract Number: 1406-P

ZEALAND SUPPORTED ITT WITH STENO DIABETES CENTER PRESENTATION DETAILS

Oral Presentation Title: Pen-Administered Low-Dose Dasiglucagon vs. Usual Care for Prevention and Treatment of Nonsevere Hypoglycemia in People with Type 1 Diabetes During Free-Living Conditions:  A Phase 2, Randomized, Two-Period, Crossover Outpatient Study
Session Title: Other Therapeutic Agents
Presenting Author: Christian Laugesen, MD – Steno Diabetes Center
Presentation Date and Time: Monday, June 6th , 2022, 8:00 – 10:00 AM (CDT)
Session Location: Hall E-3 (Level 1)
Abstract Number: 257-OR

BOEHRINGER INGELHEIM PRESENTATION DETAILS ON BI 456906
(co-invented with Zealand Pharma)

Poster Title: The Dual Glucagon and Glucagon-Like Peptide-1 Receptor (GCGR/GLP-1R) Agonist BI 456906 Reduces Bodyweight in Diet-Induced Obese Mice Based on Food Intake Reduction and an Increase in Energy Expenditure
Presenting Author: Robert Augustin, PhD – Boehringer Ingelheim

Poster Viewing Reception Date and Time: Sunday, June 5th, 2022, 12:00 - 01:00 PM (CDT)

Location:

Hall D-E

Abstract Number: 723-P

About Dapiglutide
Dapiglutide (pINN) is a long-acting GLP-1R/GLP-2R dual agonist. The Phase 1b multiple-ascending dose, safety and tolerability trial investigating dapiglutide in healthy volunteers was completed in November 2021 and dapiglutide was found to have an acceptable safety and tolerability profile. Results showed a plasma half-life allowing for once weekly dosing and effects on several biomarkers suggest clinically relevant exposures of dapiglutide were achieved.

About ZP8396
ZP8396 is a long-acting amylin analogue designed to improve solubility, minimize fibrillation and allow for co-formulation with other peptides, including GLP-1 analogues. Amylin analogues hold potential as both mono and combination therapies for obesity. In preclinical studies ZP8396 has demonstrated potent anti-obesity effects and a Phase 1 program was initiated in 2021.

About Dasiglucagon Mini-Dose
Zealand is developing a dasiglucagon mini-dose pen for potential treatment of exercise-induced hypoglycemia in people living with type 1 diabetes and for people who suffer from meal-induced hypoglycemia following gastric bypass surgery. Clinical studies conducted in hospital settings have shown the potential for using low doses of dasiglucagon to correct moderate hypoglycemia. Top-line results from a Phase 2a dose-finding trial in people with type 1 diabetes were presented at the American Diabetes Association congress in June 2021, and top-line results of a post bariatric hypoglycemia Phase 2a trial were reported in 2020. Zealand is currently conducting two out-patient Phase 2 trials, utilizing the dasiglucagon mini-dose pen in in people with type 1 diabetes and for people that suffer from meal-induced hypoglycemia following gastric bypass surgery (ClinicalTrials.gov Identifier: NCT04764968 and NCT04836273).

About BI 456906
BI 456906 is being investigated for the treatment of obesity and associated metabolic diseases. The dual glucagon (GCGR)/GLP1 receptor agonist activates both the GLP-1 and glucagon receptors and may offer better efficacy than currently available single-hormone receptor treatments. The compound leverages the known effects of the natural gut hormone oxyntomodulin, which has been shown to decrease food intake and increase energy expenditure in humans as well as the established effects of GLP-1 receptor agonists on both glucose control and body weight.

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development 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. 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 for more information about Zealand’s business and activities, please visit http://www.zealandpharma.com.

About Boehringer Ingelheim 
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com.

Forward-Looking Statements

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 labelling; 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
Maeve Conneighton
Argot Partners
investors@zealandpharma.com

Zealand Pharma Media Relations
David Rosen
Argot Partners
media@zealandpharma.com


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