Speedel initiates Ph IIa trial of SPP635

Basel, Switzerland-based Speedel has initiated a Phase IIa clinical trial with the renin inhibitor, SPP635, for the treatment of hypertension. This is the first of the next-generation compounds following Speedel's lead product SPP100 (aliskiren, Tekturna), which is partnered with Novartis and awaiting marketing approval from US and European Union regulators.

SPP635 is the most advanced compound in Speedel's SPP600 series and is one of several new proprietary renin inhibitors originated by the company's late-stage research unit. The start of the Phase IIa trial follows the successful completion of a Phase I safety and tolerability study, where plasma concentrations reached levels that were predicted by earlier human microdosing studies reported in February 2005. These supported earlier estimations that SPP635 has a bioavailability of about 25%-30% in man, with a half-life of approximately 24 hours, making it ideal for once per day dosing.

The four-week, double-blind, placebo-controlled, randomized, parallel-design, proof-of-concept Phase IIa trial in hypertension will be carried out in Europe with results due around third-quarter 2007. It will study the safety and efficacy of SPP635 in about 35 patients with mild-to-moderate hypertension by measuring office and ambulatory blood pressure.