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news.Swiss biotech firm Speedel has begun phase I safety testing of SPP635, a renin inhibitor designed for the treatment of hypertension and organ protection.
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The phase I trial, which will test the safety and tolerability of single and multiple oral doses in healthy volunteers, is expected to finish in the second half of 2006.
The compound is one of several new proprietary renin inhibitors invented by Speedel Experimenta, the company’s late-stage research unit, which was established in 2002. Not only is it designed to treat hypertension, but also protect organs such as the heart, kidneys and blood vessels.
SPP635 was selected for further testing following preclinical evaluation and human microdosing studies showed that it performed better than another candidate, SPP630.
The study is a randomized, placebo-controlled trial in healthy volunteers, designed to assess the pharmacokinetics, inhibition of the renin-angiotensin system, clinical safety and tolerability of rising single and multiple oral doses of SPP635.
Speedel’s first renin inhibitor SPP100 is currently in phase III clinical trials with Novartis, the company’s partner. Novartis is expected to file SPP100 for regulatory approval with the FDA in early 2006 for the treatment of hypertension.
Speedel said it is working on several programs to create a new generation of renin inhibitors. In addition to the SPP600 series, which gave rise to SPP635, there is the SPP800 series and other programs which are in preclinical development.
Dr Alice Huxley, CEO at Speedel said: “We believe that renin inhibition may be the new gold standard for the treatment of hypertension and related disorders in the next decade.”