Zealand Pharma announces topline results from the mechanistic investigator-led DREAM trial with low doses of GLP-1/GLP-2 receptor dual agonist dapiglutide

Company announcement – No. 27 / 2024

Zealand Pharma announces topline results from the mechanistic investigator-led DREAM trial with low doses of GLP-1/GLP-2 receptor dual agonist dapiglutide

• Mean weight loss of up to 4.3% after 12 weeks with low doses of dapiglutide treatment
• Dapiglutide was assessed to be well-tolerated
• Tolerability profile observed suggests doses investigated were at the lower end of the therapeutic range
• Much higher doses of dapiglutide are being investigated in the ongoing 13-week Phase 1b trial, with topline results expected in the second half 2024

Copenhagen, Denmark, 23 May 2024 – Zealand Pharma A/S ("Zealand") (Nasdaq: ZEAL), (CVR-no. 20 04 50 78), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced topline results from the DREAM trial (Dapiglutide for the Treatment of Obesity), the investigator-led clinical trial designed to evaluate the potential for weight loss and to gain key mechanistic insights into the effects of low doses of GLP-1/GLP-2 receptor dual agonist dapiglutide following a 12-week treatment period. No lifestyle interventions, such as diet or exercise, were part of the trial.

Treatment with dapiglutide at doses of 4 and 6 mg resulted in an observed numerical mean weight loss change from baseline of 2.9% (p=0.483) and 4.3% (p=0.077) after 12 weeks, respectively, compared to 2.2% with placebo (primary endpoint).¹

“We are encouraged by the reductions in body weight observed in this investigator-led mechanistic trial using low doses of dapiglutide. These results are in line with the outcomes observed with shorter term treatment using lower doses of other incretin-based therapies,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “Our ongoing 13-week Phase 1b dose-titration trial is currently evaluating higher doses of dapiglutide up to 13 mg, and based on the tolerability profile observed to date, we will seek to investigate even higher doses going forward. We expect topline results from our Phase 1b trial in the second half of this year.”

Dapiglutide was assessed to be safe and well-tolerated in the DREAM trial. The most common treatment-emergent adverse events were related to the gastrointestinal system, including reduced appetite and nausea. Overall, the number of events observed were lower than have been reported from studies of other incretin-based therapies, and none led to treatment discontinuation in this trial.