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Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension

Next Generation Renin Inhibitor to Continue Phase II Profiling in Diabetic Patients


BASEL/Switzerland and BRIDGEWATER NJ/USA, 28 June 2007-Speedel (SWX: SPPN) today announced that it has reached another significant milestone in the development of its family of renin inhibitors with the successful completion of a Phase IIa proof-of-concept clinical trial with SPP635 for the treatment of hypertension. Based on these positive results, the company is to 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 (aliskiren, Tekturna/Rasilez[1]), which is partnered with Novartis and recently obtained US marketing approval from the FDA and a positive opinion from the CHMP in Europe[2]. SPP635 is the most advanced compound in the SPP600 series and is one of several new proprietary renin inhibitors invented by Speedel Experimenta, the company's late-stage research unit.

Phase IIa results demonstrate strong efficacy and good tolerability
The trial had a double-blind, placebo-controlled, randomised, parallel design and it evaluated patients treated with a single dosage level of SPP635 once-daily for 4 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[3].

SPP635 was safe and well tolerated over the 4 week period. There were no serious adverse events reported nor were there any clinically significant changes in laboratory safety parameters. Sitting systolic blood pressure was significantly reduced by 17.9 mmHg from 156.6±9.1 mmHg at baseline (mean ± SD) to 138.7±13.3 mmHg in the SPP635 treated group after 4 weeks (p<0.001). The placebo group remained unchanged (156.1&plu
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