Ironwood Pharmaceuticals, Inc. IRWD and partner Astellas Pharma, Inc. ALPMY reported positive top-line data from a phase III study on linaclotide (U.S. trade name – Linzess; EU trade name – Constella) for the treatment of adults suffering from irritable bowel syndrome with constipation (IBS-C).
The randomized, double-blind, placebo-controlled study (n=500), which was conducted in Japan, achieved its primary and secondary endpoints. Results showed that patients when treated with Linzess (500 mcg) demonstrated a statistically significant improvement compared to placebo across both the co-primary endpoints. While 34% of patients reported improvement in IBS symptoms as compared to 18% in the placebo arm, 35% of patients on Linzess were complete spontaneous bowel movement overall responders compared to 19% of placebo-treated patients. The companies also reported improvement in several other secondary endpoints like abdominal and constipation symptoms, including bloating and abdominal pain/discomfort.
The phase III study also includes an additional 40-week, open-label follow-on study period, which is currently ongoing.
Based on the positive phase III top-line data, Astellas intends to seek regulatory approval in Japan in 2016. We note that Ironwood has a licensing agreement with Astellas for the development and commercialization of Linzess in Japan.
Linzess is already approved for the treatment of adults with IBS-C or chronic idiopathic constipation in the U.S. Ironwood co-markets the drug with Allergan plc AGN in the U.S. and in the EU for the treatment of adults with moderate-to-severe IBS-C.
We are encouraged by the study results. Considering that 2.9% of adults in Japan suffer from IBS-C with no prescription treatment currently available, approval would boost sales of the drug significantly.
While Astellas is a Zacks Rank #2 (Buy) stock, Ironwood carries a Zacks Rank #3 (Hold). Achillion Pharmaceuticals, Inc. ACHN is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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