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Saturday, March 14, 2015

Treatments for NASH may finallly come

I’m pretty sure not many people without medical training have heard the term of nonalcoholic steatohepatitis (NASH), In layman’s language, it is a gradual accumulation of fat in the liver not due to drinking of alcohol. NASH will significantly damage the liver function and eventually lead to life threatening liver failure. This is the disease often associated with obesity and diabetes. With the alarming worsening trend of obesity and diabetes prevalence, you can imagine how lucrative this market is. Currently there are no available therapies to treat this devastating disease, however, the treatment landscape is likely to undergo a dramatic transformation over the next five to 10 years as new therapies enter the market.

Right now, the most advanced NASH therapy in development is coming from the Wall Street darling, Intercept's (ICPT). It has already started a phase 3 study for the drug, obeticholic acid. The data up to now has demonstrated promising efficacy, however the drug seems to have some problems regarding its lipid profile and cardiovascular risk. In addition, the drug also cause pruritus, an itching side effect which could reduce patient adherence.

There is another drug in a bit earlier stage of development but also very promising. In Phase II studies to date, GFT505 from Genfit (GNFTF) has consistently demonstrated to be able to reduce markers of liver injury and inflammation and also improve the whole-body insulin sensitivity. More interesting and attractive lies in the fact that, unlike Intercept's obeticholic acid, GFT505 appears to improve the lipid profile by significantly reducing LDL-C and triglycerides. In other words, if proved in phase 3, this drug will not only great specifically for NASH but its therapeutic potential may go beyond to other non-hepatic pathologies and put itself in a strong position in terms of the prevention of cardiovascular events in prediabetic and diabetic patients. 

As with any speculation in the biotech field, uncertainty is extremely high with no any guarantee that you will win. But on the flipside, the profit potential is equally high and great. It is just the matter of the balance between the risk and reward. As long as you don’t go crazy to put yourself into an unduly high risk, betting for either of them is worthwhile. Personally I like GNFTF better.

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