MADRIGAL MGL-3196 RESULTS IN NASH SEEMS GOOD



Let's compare the results announced by MADRIGAL for their MGL-3196 this morning with those of the Elafibranor in Golden because they are the only ones to have given results with the new definition of the NASH resolution !

Some  prerequisites are to be specified:

  • The figures provided by MADRIGAL are on PP (per protocol). patients who ended the trial with a valid biopsy  and not on the ITT, (intention to treat) population as required in academic publication.
  • We will try to compare the results on identical populations with a NAS > = 4 but we do not have all the data’s , it will be necessary to wait for the full publication of MGL3196 results
  • We will compare the results of GOLDEN on the configuration retained in Phase 3 by Genfit,  ie NAS> = 4 and balanced centers. However, we will also recall Golden's results for NAS> 4 patients on all centers.

 


Three endpoints are to be examined:

  • The improvement of the NAS Score by 2pts at least
  • The resolution of  NASH
  • The improvement of the Fibrosis grade

 

 

  

The improvement of the NAS Score by 2pts at least

  For MGL3196l ,  I tried to evaluate the % of patients reaching the endpoint in the ITT population and I found 48% (vs 56%)

 

The resolution of NASH

  For MGL3196l ,  I tried to evaluate the % of patients reaching the endpoint in the ITT population and I found 24% (vs 27%)



The improvement of the Fibrosis grade

This improvement is not significant  because of the short duration of the trial, to my opinion.

 MGL-3196 29% vs Placebo 26%        

p not provided (because of its bad value t my opinion)

The improvement on the subgroup of patients with a NASH resolution is good but the same was noted with elafibranor .

We can see that the results of Madrigal  MGL 3196 are between the results of the GOLDEN trial with balanced centers and that including all the centers.

Those results seems excellents.  Nevertheless the high level of spontaneous NAS score and fibrosis improvement in the placebo arm is very surprizing and not coherent whith the placebo NASH resolution score( in line with similar trials).  Patients baselines should be analyzed deeply to understand why, we will wait for all the parameters of the trial  in an upcoming publication.


As the PPAR approach, thyroid regulators seem a very promising way to treat NASH


I COMPLETED MY ANALYSIS THERE


G Divry

Notice that I am neither a physician nor a biologist or financial analyst, my point of view is only that of an enlightened amateur, so it must be taken for what it is, a questionable point of view



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