Speedel's third renin inhibitor advances to the clinik
Strategy on track for building family of next generation compounds
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 2008. SPP676 is one of several novel compounds developed by Speedel Experimenta, the company's late-stage research unit.
Dr. Alice Huxley, CEO, commented: "Our strategy is on track for building a family of next generation compounds, and this important milestone further strengthens Speedel's position as a world leader in renin inhibition. SPP676 is the third compound developed by our in-house laboratory to enter clinical trials, following SPP635 in Phase II and SPP1148 in Phase I.
We believe that renin inhibition will become the gold standard in the treatment of cardiovascular diseases, the largest segment in the pharmaceutical industry and Speedel intends to be a significant player in this huge market."
The Phase I trial of SPP676 is a double-blind, randomised, placebo-controlled study in healthy male volunteers designed to evaluate clinical safety and tolerability following single and multiple oral doses. In addition, the pharmacokinetics and pharmacodynamics of the compound will be assessed. Testing of the single doses has started in October 2007, and the multiple-dose phase of the study is planned to start in 2008.
Speedel's first renin inhibitor SPP100 (Tekturna/Rasilez) was approved by the FDA in the US in March 2007, and by the EMEA in the EU in August 2007, and is marketed by Novartis in these markets. Both Speedel and Novartis recently won the Wall Street Journal Gold Award for Technology Innovation, which was given to the companies for their work in discovering and developing SPP100 as a novel therapy for hypertension. Speedel is developing a number of series of next generation renin inhibitors, including the SPP600, SPP800 and SPP1100 series.
About SPP600 series In June 2007 Speedel reported promising Phase IIa results with SPP635 in hypertensive patients.
SPP635 is the most advanced compound of the SPP600 series of renin inhibitors being developed by Speedel. The company has made significant progress in the optimisation and development of this series of newly synthesised compounds by using rational drug design, including computer assisted molecular modelling techniques, state-of-the art preclinical disease models and human microdosing.
In December 2001, Speedel acquired a worldwide exclusive license from Roche covering its entire programme in renin inhibition. This license allows Speedel to use the acquired know-how for lead optimisation of its own compounds designated as the SPP600 series. Speedel holds full development and commercialisation rights for these product candidates under the license agreement with Roche.
If Speedel decides to offer rights to any Speedel compound from the series to a third party, Roche has a right of first negotiation with respect to such rights. If Roche has not expressed its interest in acquiring such rights within a defined period of time, or the parties have not reached an agreement on the terms of such rights, Speedel is free to grant such rights to any third party.
Hypertension is a common disorder in which blood pressure is abnormally high, placing undue stress on the heart, blood vessels and other organs such as the kidney and the brain. Blood pressure is determined in two phases as the heart contracts and relaxes. Systolic blood pressure represents the force that blood exerts on the walls of arteries as the heart contracts to pump out blood. Diastolic blood pressure represents the force as the heart relaxes to allow the blood to flow into the heart.
Due to its wide prevalence and impact on cardiovascular health, hypertension is a major cause of disease and death in Europe and North America. More than one in three Europeans and North Americans over the age of 35 suffers from hypertension - but for the vast majority of patients who undergo hypertension treatment, the causes of high blood pressure are unknown. More than 40 % of patients undergoing treatment with current therapies do not reach targeted blood pressure levels, and so there is a considerable unmet medical need.
The latest potential therapeutic agents for hypertension are renin inhibitors. Renin is an enzyme produced in the kidneys in response to reduced renal perfusion. Through a cascade of biological events, renin acts to bring about sodium retention, an increase in blood pressure, and restoration of renal perfusion, which shuts off the signal for renin release. For hypertensive individuals, renin inhibitors are currently being investigated as a therapy that may provide benefits over current therapies to reduce blood pressure, decrease salt retention and may protect end organs such as the kidney, heart and brain.
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