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Date: 2010-03-16
Phase: II
Anouncement: Result
Biotech:
Pharma: Novartis (Switzerland)
Product: LCZ696 (first-in-class angiotensin receptor neprilysin inhibitor - ARNI) The product simultaneously inhibits both NEP, enzyme responsible for the breakdown of natriuretic peptides, and the angiotensin receptor.
Disease: hypertension
Country:
Other: Novartis announced that LCZ696 has successfully completed its first large-scale clinical trial.
1,328 patients with mild-to-moderate hypertension were randomized to receive eight weeks of treatment with one of three doses of LCZ696, three comparable doses of the angiotensin receptor blocker (ARB) valsartan, the neprilysin (NEP) inhibitor pro-drug AHU377, or placebo.
Patients receiving any one of the three active treatments achieved incremental blood pressure reductions on average over placebo. Patients who received the two higher doses of the dual-acting LCZ696 achieved significantly greater average reductions from baseline in both mean sitting systolic and diastolic blood pressure than those in the comparator arms.
Patients receiving high-dose LCZ696 also achieved superior blood pressure control rates and significantly greater decreases in pulse pressure.
LCZ696 was well tolerated, with no cases of angioedema reported.

These results have been presented at the 59th American College of Cardiology (ACC) Annual Scientific Session in Atlanta and simultaneously published online in the Lancet.

Phase III clinical development of LCZ696 in heart failure has been initiated in December 2009. The PARADIGM-HF study will assess whether LCZ696 is superior to the ACE-inhibitor enalapril in delaying the time to first occurrence of either cardiovascular mortality or heart failure hospitalization.