Positive results from linaclotide Phase 3 trial in patients with IBS-C

Almirall, S.A. (ALM:MC) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced positive top-line results from a 26-week pivotal Phase 3 clinical trial assessing the efficacy and safety of once-daily dosing of linaclotide 266 mcg in patients with irritable bowel syndrome with constipation (IBS-C).

“We continue to see that linaclotide significantly improves abdominal pain and constipation symptoms. The results of these Phase 3 data show that patients with IBS-C experienced sustained improvement of their symptoms over 26 weeks”

The two co-primary endpoints required by the European Medicines Agency (EMA) were met in this trial, showing statistically significant improvements for linaclotide-treated patients for both abdominal pain/abdominal discomfort responder (p<0.0001) and IBS degree of relief responder (p<0.0001) over the first 12 weeks. Significant improvement was also achieved for all secondary efficacy endpoints (p<0.0001) including 26-week abdominal pain/abdominal discomfort responder, 26-week IBS degree of relief responder, and change from baseline in 12-week stool frequency, stool consistency, straining, and bloating. The incidence of adverse events was similar to that observed in the previous Phase 3 trial of linaclotide in patients with IBS-C, with diarrhea being the most common adverse event in linaclotide-treated patients.

"These very positive results represent a significant milestone in the Phase 3 clinical trial program for linaclotide which has been developed specifically to provide long term relief from the symptoms of irritable bowel syndrome with constipation, an area in which a very high unmet need exists," said Per Olof Andersson, Chief Scientific Officer, Almirall.

"We continue to see that linaclotide significantly improves abdominal pain and constipation symptoms. The results of these Phase 3 data show that patients with IBS-C experienced sustained improvement of their symptoms over 26 weeks," said Mark Currie, Ph.D, Chief Scientific Officer, Ironwood. "We are looking forward to the opportunity to bring this treatment to the millions of patients suffering from IBS-C globally."

This trial, MCP-103-302, conducted in North America jointly by Ironwood and its U.S. partner Forest Laboratories, Inc., was designed to support regulatory submission for linaclotide in both Europe and the U.S. In a separate press release issued today, Ironwood and Forest announced positive top-line results from this trial for the U.S. endpoints.

Ironwood has out-licensed linaclotide to Almirall for European development and commercialization. Regulatory filing in Europe is expected in the second half of 2011. The companies expect to present detailed results of the two Phase 3 trials at appropriate scientific conferences.