Synergy Pharmaceuticals, a company that discovers and develops compounds involving uroguanylin analogs for the treatment of inflammatory bowel disease (IBD) and functional gastrointestinal disorders, recently disclosed positive Phase 1b clinical trial data on dolcanatide, a uroguanylin analog.
Uroguanylin is an amino acid peptide that regulates the transport of water and electrolytes in the intestine and kidney epithelium. It is secreted by enterochromaffin cells in the duodenum and proximal small intestine and plays an important role in the regulation of healthy digestive activity.
Dolcanatide was tested for the treatment of mild-to-moderate ulcerative colitis in a four-week, double-blind, placebo-controlled, clinical trial with 28 patients.
Results from the trial revealed that the uroguanylin analog dolcanatide is able to provide a clear health improvement in patients with ulcerative colitis compared to a placebo treatment. The analysis of the data also showed that dolcanatide was safe and well-tolerated by the patients.
“It is always encouraging when clear signals of efficacy are observed in a short-term, placebo-controlled trial such as this,” Patrick H. Griffin, M.D., EVP, and chief medical officer of Synergy Pharmaceuticals said in a press release. “These data clearly support what we have already observed in multiple pre-clinical models of inflammatory bowel disease. Given these promising results, we are excited to move this dolcanatide program forward into the next phase of clinical development.”
“This successful proof-of-concept study with dolcanatide clearly demonstrates the utility of our uroguanylin-based platform in inflammatory bowel disease and opens the opportunity for us to evaluate areas beyond functional GI [gastrointestinal] disorders,” said Gary S. Jacob, Ph.D., chairman and CEO of Synergy. “This is a major milestone achievement in what we expect to be a transformative year for Synergy.”
Synergy Pharmaceuticals has also successfully completed a phase 2 clinical trial on dolcanatide in patients with opioid-induced constipation (OIC). In addition, the company is developing other uroguanylin-based analogs for gastrointestinal disorders like chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).
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