Positive Phase 1b Trial Results for Zealand Pharma's Dapiglutide
Exciting Developments in Weight Management Solutions
Zealand Pharma A/S, a biotechnology company dedicated to innovative peptide-based medicines, has announced significant findings from its Phase 1b clinical trial of dapiglutide, a dual GLP-1/GLP-2 receptor agonist targeting weight management. This comprehensive study assessed the safety and tolerability of 13-week multiple ascending doses of dapiglutide.
Overview of Clinical Trial Results
The trial revealed encouraging results, with participants experiencing placebo-adjusted weight reductions averaging up to 8.3% following 13 weekly doses of dapiglutide. Notably, the treatment was deemed safe and well tolerated, with gastrointestinal adverse events commonly associated with other incretin therapies. As part of the ongoing evaluation, higher doses up to 26 mg are under investigation in Part 2 of the trial.
Understanding the Dapiglutide Impact
Dr. David Kendall, Chief Medical Officer of Zealand Pharma, expressed enthusiasm over these promising results, emphasizing the potential for dapiglutide to not only aid in weight loss but also have additional benefits concerning inflammation.
Phase 1b Trial Part 1 Findings
In the initial phase of the trial, 54 participants, primarily male with a median age of 46 years and a baseline BMI of 30.0 kg/m2, were randomized to receive dapiglutide or placebo. The treatment group exhibited a notable decline in weight with no severe treatment-emergent adverse events reported, aside from minor gastrointestinal issues.
Future Directions for Dapiglutide
As the trial progresses to higher doses, Zealand Pharma aims to investigate a longer treatment duration of 28 weeks, analyzing potential benefits for individuals living with overweight and obesity. Preliminary data show promising results, and the company is optimistic about launching a comprehensive Phase 2b trial.
Potential of Dapiglutide in Addressing Co-Morbidities
Additionally, Zealand Pharma is keen on studying dapiglutide’s effects on obesity-related comorbidities. By harnessing the dual-action mechanism of dapiglutide, the company aims to address severe issues linked to obesity and low-grade inflammation.
Understanding the Mechanism of Dapiglutide
Dapiglutide's unique formulation combines the benefits of GLP-1 and GLP-2 receptor activation, promoting effective weight management while potentially improving intestinal health. Initial Phase 1 results demonstrated that dapiglutide led to dose-dependent weight loss and favorable changes in plasma glucose and insulin levels.
The Connection Between Obesity and Low-Grade Inflammation
Obesity is a complex condition often characterized by low-grade systemic inflammation, which is linked to various health challenges. Zealand Pharma’s approach highlights the potential to not only facilitate weight loss but also combat inflammation-related health risks.
About Zealand Pharma
Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand Pharma (Nasdaq: ZEAL) is leveraging its expertise in peptide-based medicines, with several candidates successfully progressing through clinical stages. With ongoing partnerships in the pharmaceutical industry and a robust pipeline, Zealand is poised for future growth in innovative therapies.
Contact Information
For additional inquiries, please reach out to Adam Lange, Investor Relations Officer, or Anna Krassowska, Vice President of Investor Relations and Corporate Communications, at Zealand Pharma.
Frequently Asked Questions
What is dapiglutide?
Dapiglutide is a long-acting dual GLP-1/GLP-2 receptor agonist designed for managing weight and improving conditions linked to obesity.
What were the main findings from the Phase 1b trial?
The main findings showed a mean weight loss of 8.3% among participants receiving dapiglutide, demonstrating safety and tolerability.
When are further results expected from the trial?
Topline results from Part 2 of the trial are anticipated in the first half of the following year, alongside the planned Phase 2b trial.
What additional potential does dapiglutide have?
Dapiglutide may also play a role in addressing obesity-related comorbidities, enhancing overall health outcomes.
How can I learn more about Zealand Pharma?
For more information, you can visit Zealand Pharma's official website or contact their investor relations team directly.
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