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news.Speedel said that results in a Phase II trial with heart failure patients which were announced by Novartis show that its investigational drug is generally well-tolerated and can potentially reduce the severity of heart failure.
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The drug, SPP100, was approved by the FDA in the US in March 2007 under the trade name Tekturna and by the European Union under the trade 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. Speedel successfully developed SPP100 through phase I and II clinical trials before Novartis exercised its license-back option in 2002.
Dr Alice Huxley, CEO, said: “We are delighted with these encouraging results which demonstrate the potential of this novel class of therapy to provide patients with benefits over and beyond blood pressure lowering. It is particularly pleasing to note that the pioneering work done by Speedel in 2002 with SPP100 in heart failure patients has now been confirmed by our partner Novartis in a large clinical trial.”
The 12-week study treated 156 patients with SPP100 150mg once per day added to standard heart failure therapy of ACE inhibitors or ARBs, compared to 146 patients receiving placebo once per day on top of standard therapy. Results showed that treatment with SPP100, when used on top of standard heart failure treatment, resulted in highly significant reductions in BNP nearly five times greater than those with standard therapy alone (-61pg/mL versus -12pg/mL,) BNP is a protein produced in the heart and brain that is an accepted indicator of heart failure severity.
Unlike some other blood pressure medicines, such as most calcium channel blockers and some beta blockers which can worsen heart failure, SPP100 demonstrated good safety and a tolerability profile similar to placebo when used in this hard-to-treat patient population. When added to existing standard of care therapies, including ACE inhibitors and ARBs, as expected a slightly higher but non-significant number of patients receiving SPP100 than placebo experienced hyperkalemia. This was usually mild and did not lead to an adverse outcome, the company said.