SPEEDEL BEGINS TESTING OF RENIN INHIBITORS

Speedel has begun a Phase I trial of SPP1148, its most promising compound from a new series of renin inhibitors for the treatment of hypertension and related disease. The Phase I trial will test the safety and tolerability of single and multiple oral doses in healthy volunteers and first results are expected in the fourth quarter.

The Phase I trial of SPP1148 is a randomized, placebo-controlled study in healthy volunteers designed to assess its pharmacokinetics, its capacity to inhibit the renin-angiotensin system, clinical safety and the tolerability of rising single and multiple oral doses.

Speedel's first renin inhibitor SPP100 (Tekturna) has been filed by Novartis for approval in the United States and Europe, and the U.S. regulatory review process is expected to be completed sometime this quarter. Speedel is developing a number of series of next-generation renin inhibitors, including the SPP600, SPP800 and SPP1100 series.

Renin inhibitors are a new class of compounds under development for the treatment of hypertension, chronic renal disease and congestive heart failure. Experts estimate that more than 50 percent of all patients with high blood pressure are not adequately controlled with current drugs, and therefore physicians need additional therapeutic options, according to Speedel.