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COMPANY ANNOUNCEMENT – NO. 27/ 2022
Zealand Pharma Presents Data from Phase 1 Trial of Dapiglutide at the 82nd Annual American Diabetes Association Scientific Sessions and Announces Dapiglutide to Move into Phase 2 Trial for Obesity
Phase 1 trial showed multiple doses of dapiglutide were well-tolerated and data supports once-weekly dosing
Investigator-Initiated Phase 2 trial of dapiglutide in obesity anticipated to commence by early 2023
Data presentations for dapiglutide and other pipeline programs at American Diabetes Association (ADA) Scientific Sessions underscore Zealand’s commitment to developing innovative new peptide-based therapeutics for the treatment of obesity
Copenhagen, DK and Boston, MA, U.S. 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 medicines, today presented data from its Phase 1 trial of dapiglutide at the 82nd Scientific Sessions of the American Diabetes Association (ADA) in New Orleans and announced it will be supporting a Phase 2 investigator-initiated clinical trial of dapiglutide in obesity anticipated to commence by early 2023.
The Phase 1 results of dapiglutide, a GLP-1R/GLP-2R dual agonist, demonstrated dose dependent weight loss of up to 4.3% of baseline body weight after only four weeks of treatment. No patients developed anti-drug antibodies. The pharmacokinetics (PK) showed dose proportionality with a low inter-subject variability and a mean half-life of 123-129 hours across the four dose cohorts and supported that dapiglutide is suitable for once-weekly dosing.
Dapiglutide also demonstrated an acceptable safety profile and was found to be appropriate for once weekly injection. Multiple doses of dapiglutide were well-tolerated and the safety profile as expected for GLP-1 and GLP-2 receptor agonists. There were no serious or severe adverse events (AEs) and no withdrawals. The most frequent related AEs reported were gastrointestinal disorders and metabolism and nutrition disorders as expected from marketed GLP-1RAs.
"We believe this encouraging clinical data for dapiglutide, along with preclinical data from 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, Chief Executive Officer of Zealand Pharma. “We are excited about the strong momentum in 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, Chief Medical Officer of Zealand Pharma. “We believe that the treatment of obesity, like other metabolic disease, will benefit from targeting multiple pathways and that’s reflected in our obesity portfolio. We are advancing standalone monotherapies, combination therapies, and dual-agonists that may offer unique benefits that can help address the still significant unmet needs of those who are overweight and obese.”
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 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.
This press release contains “forward-looking statements”, as that term 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.
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