The U.S. Food and Drug Administration (FDA) has granted fast-track status to a new program focused on developing premiere treatments for both non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The initiative, announced by U.S. research company NuSirt Biopharma, hopes to target some of the fastest growing liver diseases in the world, which are commonly associated with obesity, high blood pressure and diabetes.
Currently, both NAFLD and NASH lack any approved treatments in the United States. That’s despite the fact that up to 100 million people across the country are estimated to have NAFLD, and that up to 20 million more have progressed to NASH. Both diseases are the result of fat building up in the liver, which prevents the organ’s ability to remove toxins from the blood. Together, they affect up to one-third of the U.S. population.
The FDA’s fast track designation will expedite the review of several new drugs to treat both conditions — which are now considered to be a severely unmet medical need in this country. Untreated, both conditions can lead to cardiovascular disease, liver cancer and even liver failure.
So far, NuSirt reports that preliminary study results for its new triple-combination treatments have demonstrated potential to help reduce symptoms in people affected by both diseases and have also helped prevent the onset of NAFLD and NASH in certain people.
Because of the new fast-track designation, NuSirt also has announced enrollments for an upcoming Phase 2A clinical trial called TRIPLN. The 16-week, placebo-controlled, double-blind study will evaluate the change in liver fat content, as well as metabolic and inflammatory markers among subjects receiving two different fixed-dose combos on the drugs. Initial results from the trial are expected by the end of 2016.
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