Based on the results, which demonstrated strong efficacy and good tolerability, the company says it will continue developing SPP635 in phase II in a special population of diabetic patients with mild-to-moderate hypertension.
This compound is the first of a next generation of renin inhibitors following Speedel’s lead product SPP100, which is partnered with Novartis and recently obtained US marketing approval from the FDA.
The trial had a double-blind, placebo-controlled, randomized, parallel design and evaluated patients treated with a single dosage level of SPP635 once-daily for four weeks. It studied the safety and efficacy of SPP635 in 35 male and female patients (20 patients receiving SPP635 and 15 receiving placebo) with mild-to-moderate hypertension by measuring office and ambulatory blood pressure.
According to Speedel, SPP635 was safe and well tolerated over the four week period, and significantly reduced systolic and diastolic blood pressure.
The company expects to conclude the whole phase II test series in the second half of 2008.