2009 Fierce 15 company Ironwood Pharmaceuticals has revealed positive top-line results from a Phase III clinical trial of a once-daily dosing of linaclotide in 803 patients with irritable bowel syndrome with constipation. In its third clinical trial--the drug has turned in positive results in two earlier pivotal trials--linaclotide hit the primary endpoint of relieving abdominal pain and discomfort in those with IBS. Two previous trials tested the drug for the relief of chronic constipation. In all trials, the most common side effect was diarrhea.
Linaclotide, Xconomy explains, is an orally delivered peptide that can withstand stomach acids well enough to move into the intestines, rather than into the bloodstream, where it could cause side effects. Results from a fourth study are expected before the end of the year. If the results are as positive as those from the previous three trials, Ironwood will move swiftly to file the drug with various regulators around the world.
"The results of this Phase 3 trial, combined with previously reported positive linaclotide trial results, further support our belief that linaclotide has the potential to improve abdominal pain and bowel symptoms, offering a promising treatment for individuals suffering from this chronic gastrointestinal disorder," says Ironwood CEO Peter Hecht in a statement. The company is partnered with Forest Labs in the U.S. and has out-licensed European development to Spanish drugmaker Almirall.
- here's Ironwood's release for more
- read the Xconomy article