Speedel Initiates Phase I Safety And Tolerability Testing Of Spp1148 In Healthy Volunteers
- Second new series of renin inhibitors for treatment of hypertension to enter clinical trials -
Basel/Switzerland and Bridgewater NJ/USA, 12 Jan 2007
Speedel (SWX: SPPN) announced today the initiation of a Phase I trial of SPP1148, the most promising compound from a new series of renin inhibitors for the treatment of hypertension and related end-organ disease. 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 Q4 2007. The SPP1100 series is one of several new series of renin inhibitors invented by Speedel Experimenta, the company’s late-stage research unit, which was established in 2002.
Dr. Alice Huxley, CEO, commented: “This important milestone further strengthens Speedel’s position as a world leader in renin inhibition. SPP1148 is the second compound developed by our in-house laboratory to enter clinical trials, following SPP635 which recently progressed into Phase IIa. Our strategy is to develop a Speedel family of renin inhibitors as 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, Head of Scientific Affairs, added: “Following the preclinical evaluation of two potential candidates from the SPP1100 series, SPP1148 was selected on the basis of better animal bioavailability, positive effects on renal failure models in animals, and its suitability for manufacturing. The SPP1100 series is based on a new chemical entity compared to other renin inhibitors and this diversity adds further strength to our pipeline.”
The Phase I trial of SPP1148 is a randomized, placebo-controlled study in healthy volunteers designed to assess its pharmacokinetics, its capacity to inhibit the renin-angiotensin system, clinical safety and the tolerability of rising single and multiple oral doses.
Speedel’s first renin inhibitor SPP100 (Tekturna) has been filed by Novartis for registration in the United States and Europe, and the US regulatory review process is currently expected to be completed in Q1 2007. Speedel is developing a number of series of next generation renin inhibitors, including the SPP600, SPP800 and SPP1100 series.
About Renin Inhibitors and Hypertension
Renin inhibitors are a new class of compounds under development for the treatment of hypertension, chronic renal disease and congestive heart failure. Experts estimate that more than 50% of all patients with high blood pressure are not adequately controlled with current drugs and therefore physicians need additional therapeutic options. Global antihypertensive drugs sales are forecasted by Datamonitor to grow from USD 40 billion in 2003 to USD 50 billion by 2009.
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.
Speedel is a public 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, Tekturna), the first-in-class renin inhibitor, is partnered with Novartis Pharma for development and commercialisation in hypertension; SPP100 was filed with the FDA in the US in Q1 2006, with the FDA review period extended in December 2006 by up to three months and with the EMEA in the EU in Q3 2006. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase III (on hold), SPP200 in Phase II, SPP635 in Phase Il, SPP1148 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.
In March 2006 the company raised gross proceeds of CHF 83.95 million (approximately EUR 53m or USD 64m) through the public offering of 500,000 treasury shares. Previously, as a private company, we raised gross proceeds of CHF 239 million (approximately EUR 154 million or USD 183 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 44 million). The company’s shares were listed in September 2005 on the SWX Swiss Exchange under the symbol SPPN.
 Tekturna (SPP100, Aliskiren) is a Novartis trade name
Forward looking statements
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