Zealand Pharma's GLP-1/GLP-2 Dual Agonist Shows Promise in Weight Loss Trial

Zealand Pharma has reported encouraging results from a phase 1b trial of its GLP-1/GLP-2 receptor dual agonist, dapiglutide, demonstrating significant weight loss potential in patients with obesity or overweight. The Danish biotech's latest findings reveal that the investigational drug achieved a mean body weight reduction of 11.6% after 28 weeks of treatment.

Trial Results and Dosing Regimen

The updated data comes from a cohort of 30 patients who received weekly doses of dapiglutide up to 26 mg. This higher dosing regimen, which employed a slower every-four-week dose escalation, showed improved efficacy compared to earlier results. Previously, Zealand had reported a mean placebo-adjusted reduction of up to 8.3% in body weight among 54 participants at 13 weeks, using doses up to 13 mg.

Dr. David Kendall, Zealand's Chief Medical Officer, expressed optimism about the results, stating, "We are very encouraged by the impressive weight loss with dapiglutide after 28 weeks that appears on par with the most efficacious once-weekly GLP-1 receptor agonist-based therapy on the market today, despite the almost entirely male and relatively lean trial population."

Safety Profile and Future Development

The trial data indicated that higher doses of dapiglutide were well-tolerated, with no severe or serious treatment-emergent adverse events (TEAEs) recorded. However, two participants discontinued treatment due to TEAEs, one of which was related to gastrointestinal events.

Zealand Pharma aims to use dapiglutide to treat obesity-related comorbidities driven by low-grade inflammation. The company plans to advance the asset into a phase 2 trial, now scheduled to begin in the second half of this year, a slight delay from the originally planned first-half start.

Analytical Perspectives and Market Implications

While the 11.6% weight loss narrowly missed the 12%-plus threshold that some analysts had deemed encouraging, the results are still considered promising. William Blair analysts noted that the trial's predominantly male population may have underrepresented dapiglutide's weight loss potential, as females typically experience greater weight loss in such studies.

The performance of dapiglutide in this trial puts it in competition with other GLP-1 receptor agonists in the rapidly growing obesity treatment market. However, its unique dual GLP-1/GLP-2 mechanism may offer additional benefits that could differentiate it from existing therapies.

As Zealand Pharma moves forward with its development program for dapiglutide, the pharmaceutical industry will be watching closely to see how this potential new entrant may reshape the landscape of obesity treatment options.