Zealand's GLP-1/GLP-2 Drug Rebounds with New Phase 1b Data

Zealand Pharma’s GLP-1/GLP-2 receptor dual agonist, dapiglutide, has shown encouraging results in an early-stage clinical trial after previous lower-dose trials yielded less impressive outcomes.

In the first part of a Phase 1b multiple ascending dose study, dapiglutide achieved a placebo-adjusted average weight reduction of up to 8.3% over 13 weeks. This trial involved 54 participants who were either overweight or obese, with a median baseline body mass index (BMI) of 30.0 kg/m2, as reported on Monday. Notably, the trial did not require participants to make lifestyle changes such as diet or exercise.

Dapiglutide was generally well-tolerated, with no severe side effects reported. However, two participants discontinued their treatment due to moderate vomiting, and anti-drug antibodies were found in nearly 15% of the patients. The second part of this study is ongoing and is investigating higher doses of up to 26 mg of dapiglutide over a 28-week period, with initial results expected next year.

The data from the first part of the study have provided the necessary confidence to advance dapiglutide into a comprehensive Phase 2b trial, which is expected to begin in the first half of next year, according to Chief Medical Officer David Kendall.

Earlier in May, some analysts had characterized dapiglutide's weight loss efficacy in a Phase 2a trial, which evaluated 4 mg and 6 mg doses, as “underwhelming.” The doses tested in the current Phase 1b trial are more than double those in the earlier trials.

Zealand Pharma's notable asset, an amylin analog named petrelintide, is slated to enter Phase 2b development for overweight and obese individuals in the latter half of the year. In addition to dapiglutide, the company is also collaborating with Boehringer Ingelheim on a glucagon/GLP-1 receptor dual agonist called survodutide, which is currently being tested by the German pharmaceutical company in a Phase 3 study focused on obesity.