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.
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.
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