Almirall, S.A. and Ironwood Pharmaceuticals, Inc. announced positive top-line results from a phase 3 clinical trial assessing the efficacy and safety of a once-daily dosing of linaclotide 266 mcg in patients with irritable bowel syndrome (IBS) with constipation.
The two co-primary endpoints required by the European Medicines Agency (EMA) were met in this study, showing statistical significance and clinically relevant improvement for linaclotide treated patients both for abdominal pain/abdominal discomfort responder and IBS degree of relief responder over the three-month period. Significant improvement was also achieved for all pre-specified main secondary endpoints (stool frequency, stool consistency, straining, and bloating). The safety results were consistent with those observed in previous linaclotide clinical trials, with diarrhoea being the most common adverse event in linaclotide-treated patients.
“IBS is a disease that severely impacts the quality of life of patients and linaclotide is a specific treatment developed for the relief of symptoms in this condition,” said Per Olof Andersson, executive director R&D, Almirall. “These results are very promising and we believe linaclotide will be a valuable treatment in an area with such high unmet need. We look forward to the results of the second pivotal trial in Q4 2010 led by our partner Ironwood.”
“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,” said Peter Hecht, chief executive officer of Ironwood. LIN-MD-31, conducted in North America jointly by Ironwood and their US partner Forest Laboratories, Inc., was designed to support regulatory submission in both Europe and the US.
In a separate press release today, Ironwood and Forest announce positive top-line results from this trial for the US endpoints. The trial is part of a larger phase 3 programme investigating the effect of linaclotide treatment on patients with IBS-C. The companies expect the top-line results of the second phase 3 trial to be available in Q4 2010, after which filing dates in Europe will be determined.
Ironwood has out-licensed linaclotide to Almirall for European development and commercialization. The companies expect to present detailed results of the studies at appropriate scientific conferences.
Trial LIN-MD-31 was a multicenter, randomized, double-blind, placebo-controlled trial conducted in 803 patients meeting modified Rome II criteria for IBS-C. The trial included a two week pre-treatment baseline period, a 12-week treatment period with patients receiving either a 266 mcg dose of linaclotide or placebo, and a four-week randomized withdrawal period. During the pre-treatment baseline period the mean abdominal pain score was 5.6 (on a 0 – 10 scale where 0 is no abdominal pain and 10 is very severe abdominal pain) with 88 percent of patients suffering from abdominal pain every day.
Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, Almirall researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people’s health and well being.
Ironwood Pharmaceuticals an entrepreneurial pharmaceutical company dedicated to the art and science of great drugmaking. Linaclotide, Ironwood's GC-C agonist, is being evaluated in a confirmatory Phase 3 program for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation.