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Intercept announced today 10th of February 2017  some big changes of REGENERATE study design.


1-    The Nash resolution definition was not previously defined in the trial design ( we noticed that for months)  Now it is clear, they will use the consensual definition of reversion already used by GENFIT in their RESOLV’IT NASH study.

2-     The two endpoints on fibrosis and reversion could now be reached separately, they changed the rule between it from AND to OR .

3-    The easyness induced by this second change allow Intercept to reduce the number of patients needed for Intermediary results (needed for subpart H ) to 750 patients versus 1400. And they announced the end of this recruitment mid 2017.


 What is my opinion on that changes ?

The point one was a necessity, you can't announce an endpoint in a trial and not defining what this endpoint mean and how you will measuring it.

They finally aligned their position with the FDA and their main competitor (GENFIT)  on that point.

This is not so good for OCALIVA because they never reached this endpoint in the previous studies, the SUMITOMO Japanese study used it for OCA in NASH and failed to reach it ,for all the doses.  

The second point is a good news for Intercept, because, as seen before, their chances to reach the NASH resolution endpoint were low. So, disconnecting the fibrosis endpoint allows them to imagine a success on fibrosis without a success in NASH reversion.

The third point is also a good news for Intercept , but it reveal a big mess  which is maybe the true reason of the modifications of the study design.

They were supposed to recruit 1400 patients for H1 2017 we are mid February and now they announce that they plan to end the recruitment of 750 patients only for mid 2017 ??

It mean that they were not late in recruitment but very very late !!

To my opinion, this announcement is a matter of survival for Intercept because they were on a very bad schedule (maybe one year delay in recruitment as Galmed).

The reasons of this slow recruitment are not known (I proposed a theory on that for months ) but it will be interesting to follow the futures announcements.

G Divry

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