Ironwood Pharmaceuticals, Inc.’s (IRWD) shares jumped 5.51% after the company announced the initiation of a phase IIa study on its gastroesophageal reflux disease (:GERD) candidate, IW-3718. Results from the study are expected in the first half of 2015.
The randomized, double-blind, placebo-controlled, multi-site phase IIa study (n = 90) will evaluate the efficacy, safety and tolerability of IW-3718 in GERD patients who have not shown adequate response to the current standard of care, proton pump inhibitor (:PPI). Currently available PPIs include Eisai Co., Ltd.’s (ESALY) Aciphex. The study will compare the combination of IW-3718 and PPI to placebo plus PPI.
Data from previous non-clinical studies indicate that IW-3718 could have therapeutic use in the treatment of GERD.
We are pleased with the pipeline progress at Ironwood. We believe that the successful development and subsequent approval of IW-3718 will reduce the company’s dependence on Linzess (EU trade name: Constella). Linzess, indicated for irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (:CIC), is Ironwood’s sole marketed product.
Ironwood co-markets the drug with Forest Laboratories Inc. (FRX). Net sales of the drug, as reported by Forest Labs, were $51 million in the fourth quarter of 2013, up 48% sequentially.
Ironwood is working to drive Linzess sales and is also looking to broaden Linzess’ label by expanding the targeted patient population and gaining approval for additional indications including opioid-induced constipation, pediatrics and the prevention of colon cancer.
Ironwood carries a Zacks Rank #3 (Hold). We expect investor focus to remain on the performance of Linzess, which has blockbuster potential. Some better-ranked stocks include Shire (SHPG) carrying a Zacks Rank #1 (Strong Buy).