Aiming to compete in the lucrative weight-loss drug market, Zealand Pharma on Thursday posted topline results showing its dapiglutide led to only a slight weight reduction in low doses.
Denmark-based Zealand Pharma announced Thursday the latest Phase I data for its GLP-1/GLP-2 candidate dapiglutide for treating obesity, posting modest weight loss results in low doses.
Zealand reported topline results from its DREAM trial, evaluating the potential for weight loss and the effects of low doses of dapiglutide after 12 weeks. The data show that a 4 mg dose of the drug had a numerical mean weight loss change from the baseline of 2.9%, compared to the placebo mean weight loss change of 2.2%, earning a p-value of 0.483.
The 6 mg dose fared better as the mean weight loss change was 4.3%, achieving a p-value of 0.077 versus placebo.
Lifestyle interventions such as exercise or diet were not a part of the trial. Zealand said the candidate was safe and well-tolerated in the trial, with nausea and reduced appetite being the most common adverse events.
The company also noted that the number of adverse events was lower than that of other incretin-based therapies, and there were no discontinuations in the trial. More details on the results will be presented at a future scientific meeting. Zealand expects topline results from its Phase Ib trial in the second half of 2024.
Zealand Chief Medical Officer David Kendall said in a statement that he was “encouraged” by the reductions in body weight.
“These results align with the outcomes observed with shorter term treatment using lower doses of other incretin-based therapies,” Kendall said. “Our ongoing 13-week Phase Ib 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.”
However, Thursday’s results did not impress investors as Zealand’s stock fell sharply. Still, a report from Jefferies analysts noted that while the data may appear “underwhelming,” the trial only evaluated low doses in a primarily “mechanistic study” and that additional results are due later this year.
“[Zealand] believes [dapiglutide] could deliver ≥20% weight loss with added GLP-2 activity potentially reducing systemic and gastrointestinal inflammation to drive greater improvements in cardiometabolic health,” Jefferies wrote.
Other companies are looking to cash in on the hot weight loss market. Roche’s Genentech announced last week that its candidate CT-388, which was part of the $2.7 billion Carmot buy, lowered body weight by 18.8% in a Phase I trial. This week, SixPeaks Bio emerged from stealth with weight loss candidates and the option for AstraZeneca to buy the startup.
For now, Eli Lilly and Novo Nordisk continue to dominate the weight loss sector. Earlier this month, two studies showed that Novo’s semaglutide can preserve weight loss for up to four years.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
