Ironwood's (IRWD) Functional Constipation Study in Kids Succeeds
Ironwood Pharmaceuticals IRWD recently announced positive top-line data from its phase III study evaluating its critical medicine Linzess (linaclotide) in pediatric patients six to 17 years of age with functional constipation (“FC”).
Linzess, developed by Ironwood and its partner AbbVie ABBV, is the sole commercial product in Ironwood’s portfolio. Linzess is currently indicated for the treatment of irritable bowel syndrome with constipation (“IBS-C”) and chronic idiopathic constipation (“CIC”) in adults above 18 years of age. Presently, it is not approved for use in patients below 18 years.
Functional constipation is one of the most common gastrointestinal issues in pediatric patients and currently has no FDA-approved treatments for children.
The randomized, placebo-controlled late-stage study evaluating linaclotide in FC met its primary and secondary end points.
The top-line data from the study exhibited improved frequency of spontaneous bowel movements (“SBM”) and stool consistency in subjects treated with linaclotide (72 mcg) in 12 weeks compared with the SBM frequency in the placebo arm. SBM frequency was the study’s primary endpoint.
Moreover, linaclotide-treated subjects also displayed more than a two-fold mean change in SBM from baseline compared with the placebo arm, representing the secondary endpoint.
Linzess was well-tolerated in the subjects and maintained its safety profile as depicted in previous studies of the candidate in pediatric patients with FC and irritable bowel syndrome (“IBS”).
With the positive top-line results of the late-stage study evaluating linaclotide in FC, Ironwood, with its partnerAbbVieintends to move forward with a potential submission of a supplemental new drug application (sNDA) to the FDA. If approved for this indication, Linzess (linaclotide) will potentially be the first approved therapeutic for treating FC in pediatric patients between six to 17 years of age.
Ironwood is also evaluating linaclotide in IBS-C for pediatric patients between six to 17 years.
Shares of Ironwood have declined 9.8% in the year-to-date period compared with the industry’s fall of 15%.
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Ironwood and AbbVie equally share Linzess’ brand collaboration profits or losses. The drug came up with an encouraging performance in the first half of 2022. As reported by partner AbbVie, in the first six months of 2022, Linzess (linaclotide) generated net sales of almost $480 million in the United States, compared to $475 million in the first half of 2021.
Ironwood's share of net profits from the sales of Linzess in the United States (included in collaborative revenues) was $188.8 million in the first half of 2022, up from $186.3 million reported in the same period in 2021.
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Zacks Rank and Stocks to Consider
Currently, Ironwood has a Zacks Rank #3 (Hold).
Some better stocks in the same sector are Catalyst Pharmaceuticals CPRX and Soleno Therapeutics SLNO,each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Catalyst’s earnings per share estimates for 2022 have improved from 67 cents to 70 cents in the past 30 days. The same for 2023 has improved from 79 cents to 85 cents in the same time frame.
Earnings of Catalyst missed estimates in two of the trailing four quarters, were in line in one and beat the same on the remaining occasion. The average negative earnings surprise for CPRX is 5.41%.
Soleno’s earnings per share estimates for 2022 have narrowed down from $4.20 to $4.05 in the past 30 days. The same for 2023 has narrowed from $3.00 to $2.10 in the same time frame.
Earnings of Soleno missed estimates in three of the trailing four quarters and were in line on the remaining occasion. The average earnings surprise for SLNO is 11.40%.
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