The late-stage trial met its primary multi-component endpoint and showed that linaclotide, in comparison to placebo, improved the overall abdominal symptoms of bloating, discomfort and pain in adult IBS-C patients. Furthermore, the trial also met the two secondary endpoints.
A total of 614 patients were randomized to receive placebo or LINZESS 290mcg daily once for 12 weeks, followed by a randomized withdrawal period of four weeks.
The GC-C agonist achieved a mean decrease of 29.7% from baseline in the weekly abdominal score of patients through the treatment period in comparison to 18.3% that was recorded in the placebo arm. This was the multi-component primary endpoint of the trial with the orally once daily investigational dosage of the drug delivering a clinically meaningful and statistically significant improvement in overall abdominal symptoms.
In the evaluation of the secondary endpoints, 40.5% of patients subjected to linaclotide 290mcg showed a clinically meaningful response as defined by the abdominal symptom score responder. This was in comparison to 23.4% that was recorded in the placebo arm.
Ironwood chief medical officer, senior vice president and drug development head Mike Shetzline said: “These topline results demonstrated that LINZESS can help provide overall relief of some of the multiple abdominal symptoms that IBS-C patients identify as among the most bothersome.
“As the 10th Phase III trial of linaclotide to meet its primary endpoint, this study further contributes to the robust body of evidence supporting the use of LINZESS in adults with IBS-C and further strengthens its clinical profile.”
In the US, LINZESS is marketed by Ironwood and Allergan and has approval in the country for the treatment of adults with IBS-C or chronic idiopathic constipation (CIC).
Allergan chief research & development officer David Nicholson said: “IBS-C is a frustrating and uncomfortable condition, but it can be treated. We expect that communicating the full clinical profile of LINZESS on the overall abdominal symptoms of bloating, pain, and discomfort will broaden physicians’ understanding of the appropriate patient and may help those who need to find relief.”