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There is a race underway to develop treatments for the fatty liver disease known as NASH. And for good reason — with a massive patient population and no treatments approved yet, there is money to be made.

But the companies in this race are not all built alike. The EASL liver disease research meeting, which was just held in Vienna, Austria, however, offers an opportunity to step back and sentiment-check the stature and status of the five most prominent NASH contenders.


The Fleeting Frontrunner

Unless something goes badly wrong, Intercept Pharma (ICPT) is likely to secure the first regulatory approval for a drug to treat NASH. The Intercept drug, called Ocaliva, works by reducing fibrosis, or scarring, in the liver. In more advanced NASH patients, damage caused by fibrosis can lead to cirrhosis, liver cancer, and the need for a transplant. Patients most in need of treatment, and therefore ideal, early candidates for Ocaliva, are already being identified by specialists in anticipation of the drug’s approval next year. Intercept will have a head start of three years or more on competing NASH medicines.

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  • One of the essential purposes of Phase 2 is to explore potential clinical endpoints for Phase 3. Post-hoc analysis is a normal part of this process to understand the patient subpopulation where the drug has benefit (level of fibrosis etc.) I do not understand the author’s view that a drug is flawed simply because it is following the process — exactly what Phase 2 is intended to discover.

  • Why are you so skeptical about Genfits GNFT Elafibranor? Ok there was a retrospective analysis for the scope of the ph3 study but nevertheless Elafibranor is very advanced and there is a chance in the interim analysis to file for conditional approval. Compared with all other NASH stocks GNFT looks really cheap with a market capitalization under to 1 billion.

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