Novartis Closes LCZ696 Trial Early Due To Strong Results

Novartis announced today that it is closing early the Phase III study PARADIGM-HF evaluating its investigational drug LCZ696 due to strong interim results and based on the recommendation of the Data Monitoring Committee (DMC).

LCZ696 is a first in class treatment that acts in several ways on the heart neurohormonal system and blocks receptors exerting harmful effects while actively promoting protective mechanism. LCZ696, a twice a day pill for heart failure, is an Angiotensin Receptor Neprilysin Inhibitor (ARNI) thought to reduce the strain on the declining heart and helps speed recovery.

Tim Wright, Global Head of Development at Novartis Pharmaceuticals, said “Novartis recognizes the huge global need for treatments that extend and improve the lives of people with heart failure and we believe LCZ696's unique mechanism of action could be transformative. This result is a demonstration of our commitment to developing innovative medicines that have an impact on the most important outcomes like cardiovascular mortality.”

The PARADIGM-HF is a double-blind, randomized Phase III outcome study assessing the safety and efficacy profile of LCZ696 compared to enalapril in more than 8,000 patients with heart failure with reduced ejection fraction. The drug met the efficacy endpoint of the trial. The safety profile of LCZ696 had been established in two previous interim analyses.

“The results of PARADIGM-HF are truly impressive. The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure,” said Dr. Milton Packer, Professor and Chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA and one of the two Principal Investigators of the study.

This drug is the second treatment Novartis is developing for patients with heart failure, along with serelaxin (also known as RLX030).