NASH ! SLIDES WAR IS DECLARED!

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Going through the last presentation of INTERCEPT, one can be surprised by several pages of annexes where OCA is completely absent and that deal, apparently, very distant subjects of the supposed benefits of their drug.

These pages have only one purpose, to denigrate announced qualities of ELAFIBRANOR (GFT505) in the cardio metabolic protection and improvement of insulin sensitivity.

For what reasons INTERCEPT now attack GENFIT frontally ?

Well ! It seems that the arguments previously preached in the desert by the management of GENFIT for months, the link between NASH and cardiovascular risk,  begins to diffuse among US analysts.

The fight is not on the efficacy on NASH but clearly on the positives or negatives side effects of the respective drugs ! 

There is fire to the shop and deleterious side effects of the OCA on the cardiovascular risk can no longer be swept a backhand.

GENFIT arguing so increasingly offensive on the benefits of Elafibranor beyond the simple treatment of NASH, INTERCEPT felt obliged to respond directly, attacking Elafibranor on this point.

 

 

NASH appendix of the presentation begins with a surprising slide:


icpt june 2016-glissees


 

No reference to NASH nor has the OCA .. just a reminder to the fact that the FDA withdrew approval of the combined treatment of fibrates and statins for lack of efficacy ?

What is the purpose of this slide?

Well this is clearly a direct attack against the Elafibranor, we must remember that fibrates are molecules used against diabetes and high cholesterol. Their molecular target is primarily the PPAR α, as GFT505, a PPAR α / δ agonist ..

Basically the subliminal message is:

1- FDA has withdrawn approval of a type of PPAR α to inefficiency on cholesterol when patients are already on statins.

2- GFT505 is (among others), a PPAR α !

 

On the next two slides, the attack is frank and lack of subtlety:

The first sets the tone in its title:

icpt june 2016-glissees2

 

The title is misleading since explain that GFT505 is no better than statins in lowering LDL is obvious that no one disputes.

Statins are sold for a specific indication for lowering LDL cholesterol while GENFIT has never suggested that they intend to ask for an indication Elafibranor against cholesterol. So comparing drugs with different indications which does not mean much .. especially if one is its main indication and the other not.

Furthermore this table fails to mention what is clearly written in the article published in Gastroenterology, the average 24% reduction of LDL obtained on patients of GOLDEN study was carried out on a population consisting largely of patients who were already on statins, which completely distorts the comparison.


The second slide frontally attack the Elafibranor on its earnings in diabetes

icpt june 2016-glissees-1

 

Just like statins and LDL .. this table trying to highlight the weak results of GFT505 in lowering glycated hemoglobin in relation to drugs with an indication in diabetes.

The fact that GFT505 has been initially ambition in diabetes makes this comparison a little more relevant but GENFIT has refocused on NASH, so this is not really relevant.

Again the table fails to mention that these results were obtained in patients who were mostly already under treatment with metformin, which distorts any direct comparison, if you wanted to compare the effect of TFG 505 with other drugs against diabetes, we should compare the effect of other antidiabetic used complementarily with metformin and then discover that GFT505 the results are more than respectable.

These tables are clearly the subtle disinformation on a serious competitor. 

This kind of direct attacks against a competitor is not usual, INTERCEPT seems very concerned about the quality of its competitor Elafibranor.

It does not take long to GENFIT to replicate, with some humour ! 

Just read the end of the September presentation of GENFIT to explore the response of tit for tat.

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GENFIT uses the INTERCEPT slides by adding the disastrous performance of the OCA on LDL and diabetes.

This is the story of the biter.


Moreover GENFIT completed its presentation with the desastrous results of Japanese study on OCA for NASH.


It is a hard hit !

For month , INTERCEPT try to put thoses results under the carpet and pretend that they are irrelevant, arguing on the ethnic difference between Japanese and other peoples, the small size of the population of the study (200). 

But the facts are crual, as far we know, the japanese study did not allow patients to start statin's treatment during the study as it was lately discovered in FLINT. 

So the Japanese trial can argue the have less protocol bias than FLINT and one can notice that the results are not there.

By against the prurit is omnipresent and critical .

 The results of this trials were analyzed month ago in this article 

GENFIT is offensive now, they remind analysts that OCA proved nothing in Japan on the doses currently tested in Phase 3 by INTERCEPT and the only positive and significant results of this Japanese trial are the two points down of NAS score  which is no longer a standard accepted by the FDA for the Phase 3, and only with a dose of 40 mg / day which is not tested in Phase 3 also.

GENFIT thus recalls that ,on paper, there is very little chance that phase 3 intercept in NASH can be successful because they never met in previous studies the objectives of their Phase 3.

In contrast, it enhance the fact that GENFIT ‘s criteria of phase 3 have already been achieved in Phase 2b, which is a good presage of success.


GENFIT ended with a slide on treatment adherence linked to the prurit.




The slides war is declared between the two leaders in the NASH race.




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