Ironwood Shares Positive Top-line Data From Late-Stage Functional Constipation Candidate Study In Patients Aged 6-17 Years

Ironwood Pharmaceuticals IRWD announced positive top-line data from its Phase 3 clinical trial evaluating LINZESS (linaclotide) 72 mcg in pediatric patients aged 6-17 with functional constipation (FC).

During the study, Linaclotide was generally well-tolerated, and the safety profile is consistent with previously reported studies with linaclotide in FC and irritable bowel syndrome (IBS) in pediatric patients.

A total of  330 patients were investigated in a 1:1 ratio between linaclotide or placebo. The study  data indicate that linaclotide showed a statistically significant and clinically meaningful improvement compared to placebo in 12-week SBM frequency rate (SBMs/week).

The late-stage study met its primary and secondary endpoints, demonstrating that linaclotide (72 mcg) improved frequency of spontaneous bowl movements (SBM) and stool consistency.

Tom McCourt, Chief executive officer, commented: "Our vision for LINZESS has always been simple but powerful – keep patients at the center of everything we do. We have seen the positive impacts that LINZESS has had with more than 4 million unique patients with IBS-C or chronic idiopathic constipation (CIC) treated since launch in 2012, and our team now looks forward to potentially expanding its clinical utility to the treatment of functional constipation in an underserved population."

The company is planning to share these Phase 3 top-line trial data at upcoming scientific meetings and via peer-reviewed publications.

Price Action : Ironwood shares are trading around 2 percent down at $10.65 on Tuesday at the time of publication.