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
COMPANY ANNOUNCEMENT – NO. 27/ 2022
Zealand Pharma Presents Data from Phase 1 Trial of Dapiglutide at the 82nd Annual American Diabetes AssociationScientific Sessions and Announces Dapiglutide to Move intoPhase 2 Trialfor Obesity
- Phase 1 trialshowed multiple doses of dapiglutide were well-tolerated and data supportsonce-weekly dosing
- Investigator-Initiated Phase 2 trialof dapiglutide in obesity anticipated to commenceby early 2023
- Data presentations for dapiglutide and other pipeline programs at American Diabetes Association (ADA) Scientific Sessionsunderscore 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.
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