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Ironwood to Halt MD-7246 Development After Study Failure

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Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) announced that the delayed-release formulation of its marketed drug, Linzess — MD-7246 — has failed to meet primary as well secondary endpoints in a phase II study. The study was evaluating MD-7246 in patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). Data showed that MD-7246 failed to achieve statistically significant improvements in abdominal pain compared to placebo

Based on the study data, Ironwood and its partner AbbVie (ABBV - Free Report) are planning to discontinue the development of MD-7246.

Ironwood had previously reported data from another phase II study evaluating the candidate in patients with IBS with constipation (IBS-C) in 2016. Data from the IBS-C study showed that MD-7246 numerically improved abdominal pain relative to placebo with no effect on bowel function.

Shares of Ironwood declined almost 9% on May 27, following the study data readout. The company’s shares have lost 19.9% so far this year compared with the industry’s decrease of 4.9%.


Although failure of MD-7246 is a setback for Ironwood, the company has a strong portfolio of abdominal pain drugs. Its key product is abdominal pain drug, Linzess. Sales of Linzess were encouraging in 2019. It also started 2020 on a strong note. Linzess generated net sales of $172.2 million in the United States in the first quarter of 2020. Label expansion and approval in new countries for Linzess are driving sales of the drug higher. The drug is set to achieve blockbuster status by the end of 2020.

Please note that Ironwood markets Linzess in collaboration AbbVie in the United States. The company has a collaboration agreement with AstraZeneca (AZN - Free Report) for the development and commercialization of Linzess in China. It also has a deal with Astellas for the development of the drug in Japan.

Ironwood is also looking to expand Linzess’ label into multiple abdominal symptoms.

The company is also developing an interesting candidate called IW-3718 for treating gastroesophageal reflux disease.

It is currently enrolling patients in two identical phase III studies on IW-3718. On its last earnings call, the company stated that the COVID-19 pandemic impacted enrollment in these studies and the company does not expect to report top-line data in the second half of 2020 any longer. It will provide an update when it has more clarity.

Zacks Rank & Stock to Consider

Ironwood currently has a Zacks Rank #3 (Hold).

Agenus Inc. (AGEN - Free Report) is a better-ranked stock to consider from the pharma sector. It sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Agenus’ loss per share estimates have narrowed from $1.23 to $1.14 for 2020 and from $1.26 to $1.13 for 2021 in the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 13.95%, on average.

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