Speedel Holding, with bases in Switzerland and the USA, says that it has reached late-stage preclinical profiling of a new series of renin inhibitors designated as the SPP1100 series. Speedel has applied its experience in the development of renin inhibitors for the treatment of hypertension; it has specifically designed these new compounds for higher bioavailability and increased end-organ protection, while endeavoring to maintain the excellent safety and tolerability profiles of previously-developed renin inhibitors. The compounds incorporate Speedel's intellectual property and are the subject of several filed patent applications. Depending upon the results of toxicology testing, the first compound of this SPP1100 series could potentially enter into clinical Phase I testing by the end of 2006 or early 2007.
Speedel's most advanced renin inhibitor SPP100 (Rasilez; trade name pending regulatory approval) is currently in Phase III clinical trials with partner Novartis. It is expected that Novartis will file SPP100 for regulatory approval with the Food and Drug Administration in the USA in the first quarter of 2006 for the treatment of hypertension. Speedel has previously announced progress with two series of next-generation renin inhibitors: the SPP600 series and SPP800 series. In October 2005 SPP635 started Phase I tolerability and safety trials and results are expected in the second half of 2006.
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