Zealand Pharma A/S: Positive Phase I data for ZP1848 in Crohn’s Disease
Study findings demonstrate significant increase in citrulline levels indicating enhanced gut 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.
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