Ironwood Pharmaceuticals, Inc.
) 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.
) 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.
). Net sales of the drug, as reported by Forest Labs, were $51
million in the fourth quarter of 2013, up 48% sequentially.
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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
) carrying a Zacks Rank #1 (Strong Buy).