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Stephen Harrison joins Louise Campbell and Roger Green for an insight-laden episode about challenges and opportunities in NASH drug development. This first conversation begins with an update from Stephen on what he has been working on since last appearing on the podcast. He notes new and exciting data emerging from NGM on aldafermin, an FGF19, which indicates that multiple different mechanisms are demonstrating a positive impact on cirrhosis. Stephen shares that he is “becoming more convinced that we can move the needle in this toughest to treat patient population, albeit prior to them developing decompensating disease. There is hope that this population is not too far gone and we can be impactful.”

From here he goes on to offer an impression on the outcome of FDA’s ADCOM meeting for obeticholic acid as a treatment for pre-cirrhotic fibrosis due to NASH. Among other takeaways, Stephen emphasizes the FDA’s prioritization of safety. If there are safety concerns, there is a need for mitigation strategies to de-risk those concerns. His second point is that statistical significance on a surrogate endpoint does not guarantee conditional approval from the FDA. “The therapeutic index of a drug needs to be such that you're providing a benefit in not having a potential adverse event profile that's similar, if not even higher.” In other words, is the juice worth the squeeze?  Stephen suggests that this first drug really has to set the right tone in terms of user friendliness. The ability to readily be adopted by frontline prescribers outside of the hepatology specialty is critical. As a final thought on the subject, Stephen states the appeal behind pleiotropic drugs that can attack multiple different organ systems with a single pill or injection. 

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