Zealand Pharma A/S, a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, today announced positive results from a Phase I trial of ZP1848 for the treatment of Crohn’s disease.
ZP1848 is a potent and selective GLP-2 agonist discovered by Zealand Pharma that is targeted to offer a novel treatment option for patients with Crohn’s disease due to its regenerative effect on the intestinal surface and enhancement of intestinal function.
The Phase I clinical study was conducted in 60 healthy volunteers and 10 Crohn's disease patients in remission. ZP1848 was found to be safe and well tolerated. In addition, the pharmacological effects of ZP1848 were demonstrated in the 10 Crohn’s disease patients. This was achieved by studying the biomarker citrulline, which is an indicator of the regeneration of mucosal cells and the well-being of the gut.
The results showed that there was a clear positive effect on the levels of citrulline in patients treated with ZP1848, compared to patients treated with placebo.
The increase in citrulline levels was significant and indicates that ZP1848 has an effect on enhancing epithelial growth, as well as increasing absorptive area and improving gut function.
Zealand Pharma is currently preparing a Phase IIa study including endoscopic examinations in Crohn's disease patients which the Company believes will commence in 2012.
Crohn’s disease, an inflammatory bowel disease (IBD), most commonly affects the last part of the small intestine (the terminal ileum) and parts of the large intestine. However, the disease is not limited to these areas and can affect any part of the digestive tract. Currently available treatments target the symptomatic inflammation associated with IBD whereas ZP1848 works by enhancing the regeneration and healing of the small intestine lining after an inflammatory episode in the gut.
Commenting on today’s announcement, David Solomon, Chief Executive Officer and President of Zealand Pharma, said: “We are pleased to announce positive Phase I results from this study, which has demonstrated safety and tolerability in healthy volunteers and in Crohn’s disease patients. We are excited that ZP1848 has the potential to provide an alternative treatment paradigm for patients suffering from inflammatory bowel disease.”
Zealand Pharma A/S
