Ironwood Pharmaceuticals, Inc. IRWD and partner Allergan AGN announced that they have initiated dosing of patients in the phase II study on MD-7246, its delayed release version of Linzess (linaclotide). The study is evaluating the candidate in patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D).
The phase II study is expected to enroll 400 patients and evaluate three once-daily doses – 300, 600 and 1,200 mcg of MD-7246. Data from the study is expected in the second half of 2020.
The company is also developing the candidate in patients with IBS with constipation. Data from a previously completed phase IIb study in patients with IBS-C demonstrated that MD-7246 achieved numerical improvement in abdominal pain compared to placebo.
Ironwood has a strong portfolio of abdominal pain drugs. Its key product is abdominal pain drug, Linzess. Sales of Linzess were encouraging in 2018 and it also started 2019 on a strong note. Linzess generated net sales of $161.3 million in the United States in the first quarter of 2019. 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.
The company along with its partner AstraZeneca AZN will launch the drug in China in the second half of 2019.
Linzess is approved in the United States for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (“CIC”). Ironwood and Allergan are looking to expand Linzess’ label into additional symptoms and develop the drug as a non-opioid, pain-relieving agent for IBS patients. A late-stage study is evaluating a 290-mcg dose of Linzess for multiple abdominal symptoms in addition to pain including bloating and discomfort in adult patients with IBS-C.
Ironwood separated its Soluble Guanylate Cyclase (sGC) business into a new entity named Cyclerion Therapeutics CYCN in April. This restructuring initiative is helping the company to focus on its gastro-intestinal pipeline. Moreover, the company expects to turn cash-flow positive in 2019 following this move.
However, with a single marketed product, any setback related to manufacturing or commercialization of Linzess will impact the company’s top line. The competition in target markets for Linzess is also increasing. Other available products include Takeda Pharma’s Amitiza and Motegrity, and Synergy’s (now part of Bausch Health Companies) Trulance.
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