Ironwood Succeeds In Diabetic Hypertension Phase II Study
Zacks Investment Research | Dec 04, 2017 09:05PM ET
Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) announced encouraging top-line data from a phase IIa study, evaluating its lead soluble guanylate cyclase (sGC) stimulator candidate, IW-1973, in patients with type II diabetes with hypertension.
The candidate reduced blood pressure and improved metabolic parameters like fasting plasma glucose and cholesterol in diabetic hypertensionpatients compared to baseline.
Shares of the company were up 0.9% in pre-market trading following the news. However, it was down 6.2% at the close of trade on Monday following broader market pressures. In fact, Ironwood’s shares have fallen 10.2% in the past six months, underperforming the industry ’s gain of 0.4% in that period.
The sGC candidate was evaluated in two separate phase IIa studies in diabetic patients with hypertension. One study evaluated two dosing regimens – once daily 40 mg for 14 days and 20 mg daily two times for first seven days, followed by once daily 40 mg for the next seven days. The other one was a dose escalating study.
Data from the studies showed that IW-1973 reduced blood pressure by 6.3 mmHg from baseline against 1.6 mmHg for placebo. Moreover, the candidate reduced fasting glucose and cholesterol levels by 32.5 mg/dL and 24.7 mg/dL, respectively, from baseline.
The patient population treated with IW-1973 kept their existing treatment regimen intact. The treatment regimens included separate medications for hypertension and diabetes. The encouraging results achieved by the candidate may pave the way for a potential single medication for treating both the diseases. The candidate will also be able to treat other metabolic abnormalities like high cholesterol and serum lipid levels.
Apart from these two studies, Ironwood is also developing the candidate in phase II studies for treating diabetic nephropathy and heart failure with preserved ejection fraction.
Along with pipeline progress, Ironwood’s key marketed product, Linzess, is also growing on the back of broad payer access and continued demand. However, Ironwood shares its brand collaboration profits or losses equally with Allergan plc (NYSE:AGN) . Meanwhile, a potential approval to Synergy Pharmaceuticals Inc.’s (NASDAQ:SGYP) supplemental new drug application in January next year seeking approval for label expansion of Trulance in irritable bowel syndrome with constipation will increase competition.
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