Ironwood's diabetes drug posts positive phase 2 data, but shares still dip

Cambridge, MA, and Boston
The company is developing IW-1973 for diabetic nephropathy and heart failure with preserved ejection fraction, as well as for diabetics with resistant hypertension.

Ironwood Pharmaceuticals unveiled promising topline data from a pair of phase 2a trials investigating its sGC stimulator in patients with Type 2 diabetes and hypertension.

While shares ticked up in premarket trading, the company ended Monday down 6.2%, according to Zacks.

Soluble guanylate cyclase (sGC) stimulators act on the enzyme sGC, which regulates a signaling molecule that may be important in the treatment of a number of diseases.

The company is developing the drug, dubbed IW-1973, for diabetic nephropathy and heart failure with preserved ejection fraction (HFpEF), as well as for diabetics with resistant hypertension.

The first phase 2a trial was a randomized, placebo-controlled 14-day study involving 26 patients who were taking at least one drug to manage their disease. This tested two dosing regimens of IW-1973, while the second trial was an 11-patient dose-escalation study.

Patients received either 40 mg of the drug once a day for 14 days, or they were given 20 mg daily for the first seven days and then 40 mg daily for the remaining 7 days of the trial. Overall, the company said, the results were similar for both treatment groups.

In both trials, patients exhibited a decrease in arterial blood pressure, fasting plasma glucose levels, cholesterol and triglycerides. Additionally, they also showed a drop in asymmetric dimethylarginine (ADMA), a biomarker for endothelial dysfunction and cardiovascular risk.

“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, as observed in the Phase IIa studies,” said Christopher Wright, M.D., senior vice president of global development and chief development officer at Ironwood, in a statement.

“These data further reinforce our commitment to developing IW-1973 in patients with diabetic nephropathy and in patients with HFpEF, two diseases of significant unmet need estimated to affect millions of patients around the world, and we are advancing our ongoing larger Phase II trials in these indications,” Wright said.

Ironwood has a number of other drugs in its pipeline, including one for Type 2 achalasia and a handful of gastrointestinal drugs. In July, its GERD candidate met its primary endpoints, but fell short of delivering a “meaningful improvement” on top of a proton pump inhibitor. Despite Ironwood’s attempt at a positive spin, investors were underwhelmed, driving stock down.