Now that new medicines promise for stopping countless hepatitis C patients in future years, drugmakers including Gilead Sciences Inc are turning their attention to other liver Zi Xiu Tang diseases, having a potential market that may rival the prosperity of statins, which generated more than $30 billion annually in sales at their peak.
Several information mill working on treating hepatitis B, which may be controlled although not yet cured, as well as for fatty liver conditions brought on by rising obesity, which without treatment may affect 1 / 2 of all Americans by 2030, according to the American Liver Foundation (ALF). Some of the drugs will address advanced fibrosis and cirrhosis, what are scarring that almost all liver diseases cause without effective treatments. Each of these drugs, once approved, could reach annual sales of as much as $10 billion, industry analysts said.
The majority of the treatments are now in early Phase I or Phase II numerous studies, with more informative interim data on several expected over the course of the following year.
Gilead, that was first to promote using its hepatitis C cure Sovaldi late this past year and it has been accumulating about $3 billion in sales each quarter, is a solid bet to be among the leaders in the next wave of liver therapies, experts said.
"The Gilead program is encouraging," said Dr. Naga Chalasani, director of gastroenterology and hepatology at Indiana University Hospital in Indianapolis, who is taking part in numerous studies of promising drugs from Gilead and others.
Drugmakers are working to deal with the fatty liver disease known as NASH, or nonalcoholic steatohepatitis. With no treatment, NASH can progress to liver-destroying cirrhosis and potentially cancer.
ALF estimates that non-alcoholic fatty liver disease, including NASH, affects as much as 30 % of individuals in the usa. It can be caused by bad diets and alcohol abuse, and has been associated with diabetes.
"We don't have any strategy to that condition apart from tell someone they have to lose weight," said Dr. Mauricio Lisker-Melman, director from the hepatology program at Washington University Med school in St Louis.
Intercept Pharmaceuticals has attracted probably the most attention. Just released final data from a mid-stage clinical trial showed its obeticholic acid halted NASH progression and improved liver scarring in primarily moderately ill patients. "For now, no one else has demonstrated an antifibrotic effect within this population, and I believe we are ahead of the pack for the reason that sense," said Intercept Leader Mark Pruzanski.
Intercept intends to start a Phase III trial with at least 1,000 more seriously ill patients next year.
Dr. Scott Friedman, dean for therapeutic discovery at Mt. Sinai Hospital in New York, who has worked with virtually all the businesses in the field, said most were first testing drugs in patients whose liver damage isn't advanced.
"Gilead has sort of leapfrogged that," Friedman said, tackling more severe damage, as its simtuzumab targets fibrotic scarring directly, instead of inflammation or any other drivers of disease. Reversing cirrhosis and improving liver function is "the highest bar I can think of within this business, and it would be spectacular," he said.
Gilead faces competition from several smaller companies with promising drugs in development, including Intercept, France's Genfit, Israel's Galmed, Galectin Therapeutics, Conatus Pharmaceuticals and Raptor Pharmaceuticals, specialists said.
Gilead's antibody simtuzumab blocks an enzyme called LOXL2 that is directly involved in setting up bands of collagen that form the scarring behind cirrhosis. The collagen bands, which derive from a multitude of assaults on the liver, including alcohol and substance abuse, cross link haphazardly to destroy the liver's architecture and function.
Gilead expects to possess a strong indication of whether its drug is working when one-year data from a two-year Phase II study becomes available the coming year.
"We have a very active research Zi Xiu Tang Bee Pollen program," said Mani Subramanian, head of liver disease clinical research at Gilead. "We're targeting everything: metabolic issues, inflammation and fibrosis directly." He acknowledged challenges faced by drugmakers trying to address more advanced liver disease: "It's been a graveyard for drugs that try to reverse fibrosis," Subramanian said.
Grains, I learn, are the main no-no for Paleo people. Why?