Making Strides Towards New Treatment Options for Nonalcoholic Steatohepatitis

Nonalcoholic steatohepatitis (NASH), is condition most commonly caused by obesity or type 2 diabetes. It can result in fibrosis, complications in the lung and cardiac system, liver cancer, liver cirrhosis, and death. It affects around 30 million people in the United States, or 12% of all adults. While the condition typically affects the older population, it’s now being seen in pediatric patients as well.

The NIH believes that by 2020 it will be the number one cause of liver transplantation.

The problem

Treatment options for NASH range from chemotherapy to transplants. Unfortunately, there are no approved treatments by the FDA for the condition.

Costs associated with treating NASH equate to 5 billion dollars each year in the U.S. That said, with the increasing rate of this disease, it is estimated that cost will become 18 billion by the year 2030.

One of the worst parts of this condition is that patients are asymptomatic in the early stages, giving them even fewer options when they do receive a diagnosis.

Solutions

Currently, it is not typical practice for physicians to screen for NASH during normal checkups. However, they do screen for heart disease, colon cancer, diabetes, and other conditions. Screening for NASH could mean earlier diagnosis and better options for many patients. As it is now, too many patients find out they have NASH by accident, as they are being treated for some other condition. This only complicates their diagnosis and limits their treatment options.

But earlier diagnosis is only the first step to improving this situation. The second, is better treatment options.

Current investigations

There are currently 4 Phase 3 clinical trials underway for new treatment options for NASH.

Intercept Pharmaceuticals is investigating obeticholic acid, a drug already approved to treat primary biliary cholangitis. Its been shown to improve liver cirrhosis, which could help patients avoid transplants. Interim analysis for this trial should be complete within the first half of this year.

Gilead Sciences is investigating Selonsertib and hopes to receive FDA approval soon. Additionally, they are researching the effectiveness of different combinations of drugs and hope that one of these combos will also move to a Phase 3 trial this year.

Allergan is studying Cenicriviroc as a way to reduce fibrosis in patients with NASH.

GENFIT is evaluating Elafibranor which they believe could reverse the effects of NASH by helping the liver remain in homeostasis.

Additionally, some drug development companies such as Novartis and Pfizer have begun working together to investigate various combination therapies. Due to the complexities of this disease, researchers believe combining treatments may be the best way to combat the condition.
Novartis is also working on the development of Emricasan with help of a licensing agreement with Conatus Pharmaceuticals. The drug reduces inflammation and helps stabilize the liver by stopping the death of cells. Since the liver can regenerate, the companies believe that if they can stabilize it, it may be able to repair itself.

Looking forward

There’s a lot more to still discover, but we’re moving at a fast pace to find a more effective treatment for this disease. Hopefully, we will see positive results from the 4 current Phase 3 clinical trials soon, and new treatment options becoming available for patients.

“Right now scientists and pharmacists are optimistic that a breakthrough in the field is just a few years away.”

You can read more updates on research for NASH and the current status of the disease worldwide here.


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