Ironwood reports Phase IIa data for IW-1973 demonstrating positive effects
Ironwood Pharmaceuticals (IRWD) announced encouraging top-line results from two Phase IIa studies of IW-1973, Ironwood’s lead investigational soluble guanylate cyclase stimulator, in patients with type 2 diabetes and hypertension.
Consistent with pre-clinical observations, in both studies treatment with IW-1973 led to blood pressure reductions and improvements in metabolic parameters, including reductions in fasting plasma glucose and cholesterol levels, in patients who were taking a stable regimen of therapies to manage their disease.
Elevated levels of plasma cGMP provided clear evidence of target engagement. These studies confirm a pharmacokinetic profile of IW-1973 supporting once-daily dosing and suggest broad distribution to tissues, offering the potential for extra-vascular pharmacology. IW-1973 was generally well-tolerated.
Ironwood is currently developing IW-1973 for the treatment of diabetic nephropathy and for the treatment of heart failure with preserved ejection fraction.
The company recently initiated two new Phase II dose-ranging clinical trials with IW-1973 in these indications.
The two Phase IIa exploratory studies were designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of IW-1973 in diabetic patients with hypertension on a stable regimen of medicines to manage their disease.
The studies were not designed or powered explicitly to assess efficacy, but the data yielded clear and consistent trends indicating a positive effect of IW-1973 on blood pressure, metabolic parameters and endothelial function biomarkers.
At day 14, patients treated with IW-1973 showed a mean decrease in mean arterial blood pressure of 6.3 mmHg from baseline compared to a decrease of 1.6 mmHg from baseline in patients treated with placebo, as measured by 24-hour ambulatory blood pressure monitoring, which was a 4.7% greater reduction in patients treated with IW-1973 compared to placebo-treated patients.
IRWD closed at $17.32.
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