Ironwood Pharmaceuticals, Inc. (IRWD) announced that it has commenced a phase II study on Linzess (linaclotide; EU trade name – Constella), for the treatment of opioid-induced constipation (OIC) in adult patients.
The randomized, double-blind, placebo-controlled, multi-site phase II study will evaluate Linzess in approximately 240 adult patients suffering from constipation and chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic. Patients will be administered either 145 mcg of Linzess, 290 mcg of Linzess, or a placebo for eight weeks. The primary endpoint of the study is an increase in spontaneous bowel movements (SBM) frequency.
Data from the study should be out in the second half of 2015. Ironwood has a collaboration with Actavis (ACT) for Linzess.
We note that Linzess is currently approved for the treatment of adults suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) in the U.S. In the EU, linaclotide is marketed by Almirall, S.A. under the trade name Constella for the treatment of adults suffering from moderate-to-severe IBS-C.
Currently approved treatments for OIC in adult patients with chronic, non-cancer pain include AstraZeneca’s (AZN) Movantik.
We note that Linzess is Ironwood’s sole marketed product. Linzess revenues as reported by Actavis were $123.6 million in the first half of 2014. Linzess’ label expansion should boost sales further. We expect investor focus to remain on pipeline updates as well as the commercialization of Linzess.
Ironwood currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Ampio Pharmaceuticals, Inc. (AMPE) and Actavis. Both hold a Zacks Rank #1 (Strong Buy).
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