Zealand Pharma Presents Dapiglutide Phase 1 Trial Data at American Diabetes Association 82nd Annual Scientific Session and Announces Dapiglutide Will Advance to Phase 2 Trial for Obesity

Zeeland Pharma

VSSOCIETY AANNOUNCEMENT – NO. 27/ 2022

Zeeland Pharma Present Phase 1 data Test of Dapiglutide at the 82n/a Annual A mErican Diabetes Association Scientific Sessions and Announcement Dapiglutide at Mmore in Stage 2 Test for obesity

  • Stage 1 test show several doses of apiglutide were well tolerated and Data supportyou dosage once a week

  • Iinvestigator-Initiated Phase 2 trial of apiglutide in obesity anticipated at begin by early 2023

  • Data presentations for apiglutide and other pipeline programs at American Diabetes Association (ADA) Scientific Sessions highlight Zeeland’s commitment to developing innovative new peptide therapies for the treatment of obesity

Copenhagen, DK and Boston, MA, USA June 6, 2022 Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based drugs, today presented data from its Phase 1 trial on dapiglutide at 82n/a Scientific Sessions of the American Diabetes Association (ADA) in New Orleans and announced that it will support an investigator-initiated Phase 2 clinical trial of dapiglutide in obesity, which is expected to begin in early 2023.

Phase 1 results of dapiglutide, a dual GLP-1R/GLP-2R agonist, demonstrated dose-dependent weight loss of up to 4.3% of baseline body weight after just four weeks of treatment. No patient developed anti-drug antibodies. Pharmacokinetics (PK) showed dose proportionality with low inter-individual variability and a mean half-life of 123-129 hours in all four dose cohorts and supported that dapiglutide is suitable for weekly administration.

Dapiglutide also demonstrated an acceptable safety profile and was found to be suitable for weekly injection. Multiple doses of dapiglutide were well tolerated and the expected safety profile for GLP-1 and GLP-2 receptor agonists. There were no severe or severe adverse events (AEs) and no dropouts. The most commonly reported associated adverse reactions were gastrointestinal disturbances and metabolic and nutritional disturbances, as would be expected with marketed GLP-1RAs.

“We believe these encouraging clinical data for dapiglutide, along with preclinical data for ZP8396 and BI 456906, underscore the unique potential of our investigational peptide platform to make a difference in the lives of people with obesity,” said Adam Steensberg, managing director of Zealand Pharma. “We are delighted with the strong momentum of our pipeline in this disease area and look forward to initiating the Phase 2 trial of dapiglutide in obesity by early 2023.”

“GLP-1 continues to establish itself as the cornerstone of weight loss treatments and is an important part of individual and combination therapies,” said David Kendall, Medical Director of Zealand Pharma. “We believe that treating obesity, like other metabolic diseases, will benefit from targeting multiple pathways and this is reflected in our obesity portfolio. We are advancing stand-alone monotherapies, combination therapies and dual agonists that may offer unique benefits that can help address the still significant unmet needs of overweight and obese people.

About Dapiglutide

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

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 drugs. More than 10 drug candidates invented by Zealand have reached clinical development, of which two have reached the market and three candidates are in late-stage development. In addition, licensing collaborations with Boehringer Ingelheim and AstraZeneca create opportunities for more patients to potentially benefit from the experimental Zeeland-invented peptide agents currently in development.

Zealand was founded in 1998 in Copenhagen, Denmark. For more information on Zealand’s business and activities, please visit http://www.zealandpharma.com.

Forward-looking statements

This press release contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, which provide Zealand Pharma’s expectations or forecasts regarding future events relating to research, the development and commercialization of pharmaceutical products. These forward-looking statements can be identified by words such as “aims”, “anticipates”, “believes”, “could”, “estimates”, “expects”, “anticipates”, “target”, “has the intention to”, “could”, “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. Readers are cautioned not to rely on these forward-looking statements. These forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from the expectations set forth in the present and may render any or all of these forward-looking statements incorrect, and which include, but are not limited to, the occurrence of adverse safety events; risks of unforeseen costs or delays; unexpected concerns that may arise from e additional data, analysis or results obtained during clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties related to intellectual property claims and disputes; regulatory authorities may require additional information or additional studies, or may not approve or delay approval of our drug candidates or product labeling expansions; inability 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 these forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by these statements. The foregoing sets forth many, but not all, 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 press release. We do not undertake to update these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information regarding pharmaceutical products (including compounds under development) contained herein is not intended for advertising or medical advice.

For more information, please contact:

Zealand Pharma Investor Relations
Maeve Conneighton
Slang Partners
[email protected]

Zealand Pharma Media Relations
David Rosen
Slang Partners
[email protected]

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