Ironwood pushing through mid-stage trials with nephropathy drug
- Cambridge, Mass-based biotech Ironwood Pharmaceuticals, Inc. has announced topline results of two Phase 2a studies for its soluble guanylate cyclase (sGC) stimulator. The studies were designed to look at safety, tolerability, pharmacokinetics and pharmacodynamics, and confirmed that the drug was distributed to the tissues and could be dosed once-daily.
- The added bonus in the data was that adding IW-1973 to treatments for patients with type 2 diabetes and hypertension reduced blood pressure, and lowered fasting plasma glucose and cholesterol levels. It also had an impact on triglycerides and biomarkers of endothelial dysfunction. The drug was well-tolerated.
- Ironwood is developing IW-1973 for the treatment of diabetic nephropathy and for the treatment of heart failure with preserved ejection fraction (HFpEF). The biotech recently began two new Phase 2 dose-ranging studies.
For a company that has long been focused on one product, Ironwood Pharmaceuticals, Inc. is ready to push forward with its pipeline. The biotech announced mid-stage results for one of its most promising pipeline candidates, noting "clear and consistent trends towards a positive effect of IW-1973 on blood pressure, metabolic parameters and endothelial function biomarkers."
"We are encouraged by the pharmacokinetic profile of IW-1973 that supports a once-daily dosing regimen, as well as its safety and tolerability profile," said Christopher Wright, SVP of global development and CDO at Ironwood. "In addition, we are excited to see signals of a positive impact of IW-1973 on vascular and metabolic biology important to diabetes and heart failure, particularly since they were observed on top of existing therapies."
IW-1973 is currently in Phase 2 dose-ranging studies in the treatment of heart failure with preserved ejection fraction (HFpEF).
"These data further reinforce our commitment to developing IW-1973 in patients with diabetic nephropathy and in patients with HFpEF… and we are advancing our ongoing larger Phase 2 trials in these indications," said Wright.
Ironwood could do with some income from product revenue. The company was for the longest time a one-drug company, with its main focus on the irritable bowel syndrome drug Linzess (linaclotide), which is partnered with Allergan. The company has been working hard in recent years to expand its pipeline and bring in drugs that complement its current portfolio.
Of its $86.8 million of income in the third quarter 2017, only $682,000 was from product sales. This includes AstraZeneca plc's Zurampic (lesinurad), an add-on gout treatment, and the newly-approved Duzallo, a fixed-dose combination of lesinurad and allopurinol.
- Ironwood Pharmaceuticals Statement
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