New Crohn's Disease treatment to enter clinical trials
09 Feb 2009

The US Food and Drug Administration (FDA) has approved Crohn's Disease treatment ZP1848 to be administered in humans.

Biopharmaceutical company Zealand Pharma had issued a New Drug application to the FDA and will now advance the Glucagon-Like Peptide-2 (GLP-2) into phase I clinical trials.

The study, which will be double-blind, placebo-controlled and randomised, involves an ascending subcutaneous single dose being given to healthy volunteers. Multiple doses will then be given to Crohn's Disease patients.

GLP-2 has already been shown to increase animal survival in different types of gut injury, including Inflammatory Bowel Disease (IBD).

Dr David Solomon, Zealand Pharma's president and chief executive officer, said the advancement of ZP1848 "further strengthens" the company's ongoing developments.

"The inadequacies of the current treatment options in Crohn's Disease coupled with the rise in the incidence of IBD in the industrialized world highlights the need for more efficacious therapeutic approaches for the treatment of IBD," he said.

Crohn's Disease is most common in the ileum, although it can affect any part of the digestive tract, including the mouth, oesophagus and stomach.

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