Zealand Pharma advances bowel drug to Phase I trials

Zealand Pharma, a Denmark-based biopharmaceutical company, has advanced ZP1848, a glucagon-like peptide-2 agonist, into Phase I clinical trials. ZP1848, a peptide which incorporates the company’s proprietary SIP technology, is developed as a therapy for the prevention and treatment of Crohn’s disease.

The Phase I study is a double-blind, placebo-controlled, randomized, ascending subcutaneous single dose in healthy volunteers followed by multiple dosing in Crohn’s disease patients. The study will be conducted in the US.

Glucagon-like peptide-2 (GLP-2) is a naturally occurring peptide hormone, secreted by the small intestine. GLP-2 binds to and acts exclusively via the GLP-2 receptor, expressed primarily in the gastrointestinal tract. ZP1848 is expected to induce and maintain remission by enhancing the regeneration and healing of the small intestinal lining after an inflammatory episode in Crohn’s disease.

Zealand Pharma said that ZP1848 has been tested in an extensive preclinical toxicology and safety pharmacology program. The company is currently running a Phase I trial to assess the safety and tolerability of ZP1848 in healthy volunteers and Crohn’s disease patients. Future plans include the testing of ZP1848 in ulcerative colitis.

David Solomon, president and CEO of Zealand Pharma, said: Advancing ZP1848 into clinical trials further strengthens our development pipeline. Zealand Pharma has applied its knowledge of peptide optimization and its SIP technology to develop a series of novel peptides that specifically enhance the growth and function of the lining of the small intestine.

There is a strong need for drugs that are able to act as a mucosal regeneration enhancer and we believe that ZP1848 is a promising drug candidate for the treatment of inflammatory bowel disease.