COMPANY ANNOUNCEMENT – NO. 27/ 2022
- 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
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
“GLP-1 continues to establish itself as the cornerstone of weight loss treatments and is an important part of individual and combination therapies,” said
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
About
Zealand was founded in 1998 in
Forward-Looking Statements
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2022 GlobeNewswire, Inc., source