Ironwood Pharmaceuticals announced that the Phase 3 clinical trial of linaclotide 72mcg in adults with chronic idiopathic constipation (CIC) met its primary endpoint.

The randomized, double-blind, placebo-controlled, multi-site Phase 3 clinical trial enrolled 1,223 adults with CIC. Patients were randomized to receive linaclotide 72mcg once daily, linaclotide 145mcg once daily, or placebo for 12 weeks. The primary endpoint was 12-week Complete Spontaneous Bowel Movements (CSBM) Overall Responder, defined as a patient who experienced ≥3 CSBMs per week and an increase of ≥1 CSBM from baseline in the same week (Weekly Responder), and achieved both of these measures for nine out of 12 weeks. Additionally, a pre-specified sensitivity analysis was conducted for the Durable 12-week CSBM Overall Responder endpoint, which includes patients that were 12-week CSBM Overall Responders and also met the Weekly Responder criteria for at least three of the last four weeks. The 145mcg dose was included as a positive control and supported the validity of the trial for evaluation of the 72mcg dose.

Study results showed that the 72mcg dose of linaclotide demonstrated statistically significant improvement compared to placebo on the 12-week CSBM Overall Responder endpoint. The 72mcg dose also demonstrated statistically significant improvement compared to placebo on the Durable CSBM Overall Responder endpoint, which is currently being requested by the FDA for Phase 3 CIC trials.

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Ironwood and partner Allergan intend to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the first half of 2016.

Linaclotide, marketed as Linzess, is a guanylate cyclase‐C (GC‐C) agonist currently approved for the treatment of adults with CIC (145mcg) and adults with irritable bowel syndrome with constipation (290mcg).

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