- Ironwood Pharmaceuticals Inc IRWD announced topline data from a phase 3 study evaluating Linzess (linaclotide) 72 mcg in pediatric patients aged 6-17 years with functional constipation.
- That Study met its primary and secondary endpointsshowing that linaclotide (72 mcg) improves frequency of spontaneous bowel movements (SBM) and stool consistency.
- Linaclotide was generally well tolerated and the safety profile is consistent with previous studies.
- In this study, 330 patients were randomized in a 1:1 ratio between linaclotide and placebo.
- Related: Jefferies is raising the target price on this standout small-cap biotech stock.
- There is currently no FDA-approved pediatric therapy for functional constipation, which affects an estimated 4 to 6 million children ages 6 to 17 in the United States
- The most commonly reported treatment-emergent side effect was diarrhea, which occurred in 4.3% of linaclotide-treated participants compared to 1.8% in the placebo group.
- Linzess is developed and marketed by Ironwood and AbbVie Inc ABBV in the US and is indicated for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. It is not approved for use in patients under the age of 18.
- Price promotion: IRWD shares are up 1.10% to $11.00 during the premarket session on the last control Tuesday.
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