Ironwood Pharmaceuticals, Inc. IRWD along with partner Allergan AGN announced positive top-line data from the phase IIIb study on Linzess (linaclotide) for treating multiple abdominal symptoms in adult patients with irritable bowel syndrome with constipation (IBS-C).
The study met both primary and secondary endpoints with statistical significance and showed that Linzess improved the overall abdominal symptoms of bloating, pain and discomfort in adult patients with IBS-C as compared to placebo.
Shares of Ironwood were up almost 8.1% following this news on Tuesday. In fact, the stock has rallied 11% so far this year, outperforming the industry’s rise of 6.6%.
Linzess is marketed to treat IBS-C as well as chronic idiopathic constipation (CIC) in the United States and across 30 other countries. It is commercialized in collaboration with Allergan in the United States. Ironwood and Allergan co-develop and co-commercialize Linzess and equally share the U.S. collaboration profits or losses as well as development costs of the drug.
Linzess is marketed by Allergan for IBS-C in Europe and Canada under the brand name, Constella.
However, in the United States, majority of adult IBS-C patients complain of symptoms, such as abdominal bloating, pain and discomfort at least once a week. If approved, this new indication would expand the eligible patient population for the drug and drive its sales higher.
This double-blind placebo-controlled phase IIIb study evaluated the safety and efficacy of Linzess 290 mcg in adult IBS-C patients, who took the drug once daily for 12 weeks, followed by a four-week withdrawal period. The primary efficacy endpoint measured the change in patients’ abdominal score based on daily assessments of their abdominal bloating, discomfort and pain. Additional endpoints included change in the spontaneous bowel movement frequency, complete spontaneous bowel movement frequency, stool consistency and straining.
Ironwood plans to present additional results from this analysis at an upcoming scientific conference and via peer-reviewed publications.
Notably, Linzess has performed encouragingly on the back of strong demand and expansion in new patient population and geographical regions. Sales of Linzess were impressive in 2018 and the drug also started 2019 on a strong note. It generated net sales of $161.3 million in the United States during the first quarter of 2019. Label expansion and approval in new countries for this medicine are driving its sales higher. The product is set to achieve a blockbuster status by 2020 end.
Earlier this month, Ironwood and Allergan initiated its dosing in the phase II study on MD-7246, a delayed release version of Linzess. The study is evaluating the candidate on patients suffering abdominal pain associated with irritable bowel syndrome alongside diarrhea (IBS-D). Top-line data from the study are expected in the second half of 2020.
Earlier this January, Linzess received an approval in China for IBS-C. The company along with its partner AstraZeneca AZN will launch the same in the country in the second half of 2019. This, in turn, is likely to boost Ironwood’s top line.
Zacks Rank & Key Pick
Ironwood currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Evotec AG EVTCY, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Evotec’s earnings estimates have been revised 14.4% upward for 2019 and 41.2% for 2020 over the past 60 days. The stock has surged 32.7% year to date.
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