Zealand Pharma Reports Positive Phase 1b Trial Results for Dapiglutide

Zealand Pharma has announced promising findings from a recent Phase 1b clinical trial involving their novel drug, dapiglutide. This drug is a dual receptor agonist targeting GLP-1 and GLP-2, aimed at addressing obesity and its related comorbidities. The trial, conducted over 28 weeks, demonstrated significant weight loss among participants treated with dapiglutide, with an average reduction of 11.6% in body weight. This outcome is particularly noteworthy given the trial's demographic, with 95% of participants being male and having a baseline Body Mass Index (BMI) of 28.5 kg/m².

The clinical trial, held in Copenhagen, Denmark, was a double-blind, placebo-controlled study, emphasizing the safety and tolerability of dapiglutide. Participants were subjected to escalating doses of the drug, reaching up to 26 mg. Importantly, no lifestyle changes such as diet or exercise modifications were incorporated into the trial, which suggests that the weight loss results can be attributed directly to dapiglutide's efficacy. The trial underscored the drug's safety profile, with gastrointestinal side effects reported consistent with those of other incretin-based therapies. These adverse events were mostly mild, with common symptoms including nausea and vomiting. Only two participants withdrew from the trial due to these issues, which were primarily gastrointestinal in nature.

Dapiglutide's unique mechanism involves dual receptor activity, where alongside GLP-1 receptor stimulation, it also harnesses GLP-2 receptor activity. This dual approach is designed to combat obesity-related conditions driven by low-grade inflammation. Obesity can lead to systemic inflammation due to compromised intestinal barrier function, often referred to as "leaky gut." By improving this barrier function, dapiglutide could potentially address several comorbidities associated with obesity, such as cardiovascular disease and liver disease.

The Phase 1b trial consisted of two parts. Part 1 involved 54 participants across three cohorts, receiving 13 weekly doses of dapiglutide or a placebo. The results from this initial phase showed a placebo-adjusted weight reduction of up to 8.3% with dapiglutide after 13 weeks. In contrast, Part 2 included 30 participants receiving 28 weekly doses of dapiglutide or placebo, with dose escalation every fourth week. The findings from Part 2 were particularly encouraging, showcasing a substantial weight loss without lifestyle changes.

Zealand Pharma, established in 1998 and headquartered in Copenhagen, is a biotechnology firm dedicated to developing peptide-based medicines. The company has successfully introduced several drug candidates into clinical trials, with some having reached the market. Their development efforts focus on innovative therapies that address unmet medical needs, particularly in the area of obesity and related health conditions.

Dapiglutide's development highlights the potential of dual receptor agonists in the treatment of complex diseases like obesity. By targeting both GLP-1 and GLP-2 receptors, Zealand Pharma aims to offer a treatment option that not only promotes weight loss but also addresses the broader spectrum of obesity-related health issues. This approach reflects the company's commitment to advancing medical science through peptide innovation. As Zealand Pharma continues to explore dapiglutide's full capabilities, these trial results pave the way for further research and development in the fight against obesity and its comorbidities.