An experimental hypertension therapy in Novartis' pipeline has cleared an important mid-stage clinical trial hurdle and is headed for a pivotal test. Researchers for the pharma giant say that LCZ696--a combination of the experimental AHU377 with the standard drug Diovan-- significantly better than Diovan alone. And the combo therapy clearly outperformed a placebo.
LCZ696 is a new molecule created from the combination of AHU377 and Diovan. AHU377 is a new kind of drug similar to Bristol-Myers Squibb's omipatrilat, which was once thought to be a potential blockbuster before signs of dangerous side effects scuttled the program. This new therapy is designed to enhance the body's natural blood-pressure lowering machinery. The drug blocks angiotensin-2--which constricts blood vessels--while spurring a natural diuretic the body generates to help ease blood pressure.
In a study with 1,215 patients spread around 18 countries, the combo therapy performed almost twice as well as Diovan alone at a dose of 200 mg. And the rate of reduction in systolic levels fell in the same category as significant weight loss or a diet that concentrates heavily on fruit and vegetables.
"These findings build promise for this novel drug class. In addition, these study results demonstrate the potential for managing cardiovascular diseases through enhancement of the beneficial effects of the body's own natriuretic peptides via neprilysin inhibition and concomitant blockade of the angiotensin receptor," writes principal investigator Luis Ruilope. Significantly, patients taking the therapy had the same side effect profile as the placebo group. And if Novartis can successfully navigate Phase III, they may have a new standard of care in a huge market. Some 75 million American adults suffer from high blood pressure. But this is one field where safety issues can present enormous, and often unexpected, obstacles.