Zealand Pharma Announces Successful Outcome of Phase 1b Clinical Trial With GLP1-GLP2 Dual Receptor Agonist
Zealand Pharma A/S recently announced topline results from its Phase 1b multiple ascending dose trial with dapiglutide.
In this randomized, double-blind, placebo-controlled, multiple ascending dose trial, four cohorts of 10 healthy subjects were allocated to 4 different dose levels, randomized to either 4 weekly doses of dapiglutide or placebo. The objective of the trial was to evaluate the safety and tolerability of multiple doses of dapiglutide. Additionally, the pharmacokinectics and pharmacodynamics of dapiglutide were assessed during this trial.
Treatment with dapiglutide was associated with higher rates of gastrointestinal symptoms at the highest doses, with side effects being in line with what was observed in Phase 1a. No subjects withdrew from the study and overall, dapiglutide was assessed to be safe and well tolerated in the study. Dapiglutide displayed a linear dose-response for the pharmacokinetics parameters with a half-life of approximately 120 hours giving the possibility for once weekly dosing. For pharmacodynamics, a dose-response relationship was found for several biomarkers suggesting that clinically relevant exposures of dapiglutide were achieved in the study.
“We are thrilled with the successful outcome of this Phase 1b clinical trial with dapiglutide and look forward progressing the molecule to the next development phase next year” stated Adam Steensberg, Chief Medical Officer at Zealand Pharma. “Dapiglutide, is a first-in-class peptide drug candidate with dual activity on the GLP1 and GLP2 receptors and thus potential to address several metabolic and gastrointestinal diseases, including short bowel syndrome.”
The trial evaluated multiple ascending doses of dapiglutide assessing safety, tolerability, pharmacokinetics, and pharmacodynamics. The trial was conducted at one site in Germany. In light of the results of the trial, Zealand will be exploring several potential indications in gastrointestinal and metabolic diseases where dapiglutide’s profile could provide new treatment options including Short Bowel Syndrome.
Dapiglutide (pINN) is a long-acting GLP-1R/GLP-2R dual agonist, with a plasma half-life of approximately 120 hours. The molecule has the potential to promote mucosal healing, improve the intestinal barrier function, and enhance liver metabolism .
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery, development, and commercialization of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. In addition, license collaborations with Boehringer Ingelheim and AstraZeneca create opportunity for more patients to potentially benefit from Zealand-invented peptide investigational agents currently in development. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in Boston, and Marlborough (MA). For more information, visit http://www.zealandpharma.com.
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