BioWorld International Correspondent

A week after gaining European Union approval for SPP100 (aliskiren) in hypertension, Speedel Holding AG and partner Novartis AG unveiled Phase II clinical data indicating potential for the same compound in heart failure.

The data were delivered at a late-breaking session at the European Society of Cardiology Congress in Vienna, Austria, Sunday, by clinical investigator John McMurray, of the University of Glasgow, in Scotland.

They indicated that SPP100, marketed in the U.S. and the EU as Tekturna and Rasilez, respectively, caused a fivefold reduction in levels of brain naturietic peptide (BNP), a biomarker that, Speedel said, provides an indication of the severity of heart failure.

The 12-week study, dubbed ALOFT (ALiskiren Observation of Heart Failure Treatment), treated 156 patients with SPP100 (150 mg once daily) plus standard therapy comprising angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), while 146 patients received placebo plus standard therapy.

Those in the treatment arm exhibited a reduction of 61pg/ml of BNP, whereas those in the placebo group experienced a reduction of 12pg/ml. The result was statistically significant (p=0.016).

"From our point of view, this is the first sign that this new mode of action can have a benefit beyond blood pressure," Nick Miles, director of communications and investor relations at Basel, Switzerland-based Speedel, told BioWorld International.

SPP100 is an oral inhibitor of renin, the rate-limiting enzyme in the Renin Angiotensin System, a signal cascade that has an important role in regulating blood pressure.

However, it will be some time yet before its full potential in heart failure can be assessed clinically.

"Yes, it's early days, and Novartis has to do long-term morbidity and mortality studies, which will take three to four years," Miles said. It's also early days in the marketing of SPP100 in its lead indication. Speedel reported revenues of around CHF1 million (US$0.8 million) in the second quarter, following FDA approval for the drug in March.

Basel-based Novartis also is conducting biomarker studies of SPP100 in two other indications - in left ventricular hypertrophy and diabetic nephropathy.