SPP100 (Tekturna/Rasilez) reduces left ventricular hypertrophy

Latest study reveals further potential benefits of renin inhibitor in heart disease


Speedel welcomed promising results from the latest SPP100 (Tekturna/Rasilez) surrogate marker clinical trial which were announced by Novartis. The study results show that SPP100, the first-in-class direct renin inhibitor, has shown clinically meaningful reductions in left ventricular hypertrophy, a proven predictor of heart disease, that are comparable to those seen with the current standard-of-care treatment. Left ventricular hypertrophy (LVH) is an abnormal thickening of the heart muscle and often results from high blood pressure.

Dr Chris Jensen, Head of Scientific Affairs, said: "This data is yet another important step forward in demonstrating the full potential of SPP100 to treat both hypertension and its consequences, which so often lead to debilitating or fatal illness. As the data from Novartis' ongoing studies are published over the next few years we believe that clinicians will become increasingly convinced of the potential for SPP100 to benefit patients in ways that go beyond other types of drugs."

The ALLAY (ALiskiren Left ventricular Assessment of hypertrophY) 36-week study treated 460 patients with SPP100, losartan or a combination of the two. Results showed that treatment with SPP100 alone reduced LVH as effectively as the angiotensin receptor blocker (ARB) losartan (-5.4% vs -4.7% respectively) after nine months of therapy, despite patients having very well-controlled baseline blood pressure. The combination of both medicines achieved a numerically greater reduction in LVH than losartan alone, but the result was not statistically significant. Alone and in combination, SPP100 was well-tolerated.

SPP100 was approved by the US Food and Drug Administration (FDA) in the US in March 2007 under the trade name Tekturna and by the European Union under the name Rasilez in August 2007 to treat hypertension both as monotherapy and in combination with other anti-hypertensives. Novartis announced in July 2007 that it was also approved in Switzerland and in January 2008 that the FDA had approved it in combination with a diuretic to treat hypertension. Speedel successfully developed SPP100 through Phase I and II clinical trials before Novartis exercised its license-back option in 2002.

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