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Speedel Starts Phase I Safety and Tolerability Testing of SPP635 in Healthy Volunteers

Posted on: Thursday, 13 October 2005, 03:00 CDT

BASEL, Switzerland, and BRIDGEWATER, N.J., Oct. 13 /PRNewswire/ -- Speedel announced today the start of its Phase I safety and tolerability testing of SPP635, one of a new series of renin inhibitors for the treatment of hypertension and for protecting end-organs such as the heart, kidneys and blood vessels. The Phase I trial, which tests the safety and tolerability of single and multiple oral doses in healthy volunteers, is expected to finish in the second half of 2006. This 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.

Dr. Alice Huxley, Chief Executive Officer, commented: "This milestone is of major strategic importance for Speedel as SPP635 is the first drug which we have progressed into Phase I from our own research laboratory and reinforces Speedel's position as a leader in renin inhibition. Our strategy is to develop and bring to market a Speedel family of renin inhibitors and we believe that renin inhibition may be the new gold standard for the treatment of hypertension and related disorders in the next decade."

Dr. Chris Jensen, Director of Pharmacology, added: "Following the full preclinical evaluation and human microdosing studies of two potential candidates, SPP630 and SPP635, we have selected SPP635 for testing in healthy volunteers due to its better performance."

The Phase I trial 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 our partner Novartis; it is anticipated that Novartis will file SPP100 for regulatory approval with the FDA in the US in early 2006 for the treatment of hypertension. Speedel 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 pre-clinical development.

About Hypertension and Renin Inhibitors

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. Global antihypertensive drugs sales are forecasted by Datamonitor to grow from USD 42 billion in 2004 to over USD 50 billion by 2009 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.

Inhibition of renin, articulated as Plasma Renin Activity (PRA), is believed to be very important in end-organ protection (e.g. heart and kidney). PRA is an independent and surrogate marker for several cardio-renal diseases, such as myocardial infarction and chronic renal disease. It is only a Renin Inhibitor that lowers PRA efficiently, whereas most current leading antihypertensive drug classes such as ACEIs and ARBs increase PRA levels.

About Human Microdosing

Human microdosing is a new concept pioneered by Xceleron Ltd in the United Kingdom (http://www.xceleron.com/ ). Microdosing relies on the ultrasensitivity of Accelerator Mass Spectrometry (AMS), one of the most sensitive measuring devices ever invented. Using AMS it is possible to conduct a full human metabolism study after administration of as little as 0.1 milligram of drug substance, measuring drug concentrations in biological fluids up to 1000 times less than the levels one would observe in a classical Phase I clinical study.

About Speedel

Speedel is a biopharmaceutical company that seeks to create value for patients, partners and investors by developing innovative therapies for cardiovascular and metabolic diseases. Speedel is a world leader in renin inhibition, a promising new approach with significant potential for treating cardiovascular diseases. Our lead compound SPP100 (Aliskiren), the first-in-class renin inhibitor, is partnered with Novartis for Phase III development and commercialisation in hypertension with filing for registration expected in 2006. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase III, SPP200 in Phase II, SPP635 in Phase I, and several pre-clinical projects.

Speedel develops novel product candidates through focused innovation and smart drug development from lead identification to the end of Phase II. We either partner with big pharma for Phase III and commercialisation in primary-care indications, or we may ourselves complete Phase III development in specialist indications. Candidate compounds for development and the company's intellectual property come from our late-stage research unit Speedel Experimenta and from in-licensing.

Our team of approximately 70 employees, including over 30 experienced pharmaceutical scientists, is located at our headquarters and laboratories in Basel, Switzerland and at offices in New Jersey, USA and Tokyo, Japan. Since being founded in 1998, we have raised gross proceeds of CHF 239 million (approximately EUR 154 million or USD 191 million) from private placements of equity securities and two convertible loans and we have had total revenues, principally from milestone payments, of CHF 57.7 million (approximately EUR 37 million or USD 46 million). The company's shares were listed on the SWX Swiss Exchange under the symbol SPPN on 08 September 2005.

Forward looking statements

This press release includes forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements are based on our current expectations and projections about future events. All statements, other than statements of historical facts, regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The word "may" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations described in these forward-looking statements and you should not place undue reliance on them. There can be no assurance that actual results of our research and development activities and our results of operations will not differ materially from these expectations. Factors that could cause actual results to differ from expectations include, among others: our or our partners' ability to develop safe and efficacious products; our or our partners' ability to achieve positive results in clinical trials; our or our partners' ability to obtain marketing approval and market acceptance for our product candidates; our ability to enter into future collaboration and licensing agreements; the impact of competition and technological change; existing and future regulations affecting our business; changes in governmental oversight of pharmaceutical product development; the future scope of our patent coverage or that of third parties; the effects of any future litigation; general economic and business conditions, both internationally and within our industry, including exchange rate variations; and our future financing plans.

CONTACT: Nick Miles, Director Communications & Investor Relations,T- +41-61-206-40-00, D- +41-61-206-40-14, F- +41-61-206-40-01,M- +41-79-446-25-21, E- nick.miles@speedel.com, or Frank LaSaracina, ManagingDirector, T- +1-732-537-2290, F- +1-732-537-2292, M- +1-908-338-0501,E- frank.lasaracina@speedel.com, both of Speedel Pharmaceuticals, Inc.

Speedel Pharmaceuticals, Inc.

Web site: http://www.speedel.com/

Source: PRNewswire

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