If enrollment in Intercept’s Phase III trial of Ocaliva remains consistent the drug could be the first NASH therapy to market.
By Jack Allen, Analyst
19 July 2016
I am an analyst at Datamonitor Healthcare based in the New York office, where I am currently a member of the cardiovascu...
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If Intercept is able to continue to enroll patients at a consistent rate in the pivotal Phase III trial, then Ocaliva (obeticholic acid; Intercept Pharmaceuticals/Dainippon Sumitomo) may be able to gain a first-to-market advantage over key competitor elafibranor (Genfit SA). This first-to-market advantage would significantly increase Ocaliva’s commercial potential as physicians are looking to rapidly adopt new non-alcoholic steatohepatitis (NASH) therapies. With no drugs currently approved for this indication, there is a major void in the market as physicians seek an efficacious treatment, and becoming the first medication approved for NASH would mean Ocaliva could fill this void.
Intercept has indicated that it anticipates enrollment in its pivotal Phase III REGENERATE trial of Ocaliva in NASH patients to be completed in the first half of 2017. The company plans to file a New Drug Application (NDA) for the use of Ocaliva in NASH patients based on interim data from the REGENERATE study. If Intercept is able to continue to enroll patients at a consistent rate the interim data should be available in the second half of 2018, providing the opportunity to file its NDA before the end of 2018. Intercept’s key competitor in the race to become the first company with an approved NASH therapy is Genfit, which is the only other company with a molecule in Phase III development for this indication (Biomedtracker, 2016). Genfit indicated that it plans to file an NDA for elafibranor in Q4 2018. The table below summarizes the estimated relative timelines of the two medications’ pivotal Phase III trials.
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