ELAFIBRANOR INTERMEDIATE RESULTS OF PHASE 3, DECEPTION ! 

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Today , GENFIT released the first intermediate results of their trial RESOLV'IT, ELAFIBRANOR in NASH with fibrosis.


RECALL

RESOLV’IT is a Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Elafibranor 

Study Type  : Interventional  (Clinical Trial)

Estimated Enrollment  : 2000 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

Official Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

Study Start Date  : March 2016


  The data intermediary published on 1000 patients show :

  • 333 patients who received placebo
  • 666 patients receiving a dose of ELAFIBRANOR of 120 mg / day



The expected intermediate results focused on one primary endpoint:

  • Proportion of Elafibranor treated patients relative to placebo achieving resolution of NASH without worsening of fibrosis [ Time Frame: Measurement at 72 weeks ]


(To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) subjects with fibrosis by assessing the following endpoint: The proportion of Elafibranor treated patients relative to placebo achieving NASH resolution without worsening of fibrosis.)


Two secondary outcomes are also interesting to follow:


1- Proportion of Elafibranor treated patients relative to placebo achieving improvement of fibrosis [ Time Frame: Measurements at 72 weeks ]

To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) subjects by assessing the following endpoint: The proportion of Elafibranor treated patients relative to placebo achieving improvement of liver fibrosis of at least one stage.


2- Proportion of Elafibranor treated patients relative to placebo achieving improvement in histological scores in NASH [ Time Frame: Measurements after 72 weeks of treatment and up to study completion estimated at 4 years of treatment ]

  • Percentage of patients with resolution of NASH without worsening of fibrosis (study completion)
  • Percentage of patients with improvement of fibrosis of at least 1 stage
  • Percentage of patients with at least 1 point improvement in histological scores in NASH


 


DECEPTING RESULTS

The published results on the first endpoint are the following:

Proportion of ELAFIBRANOR treated patients relative to placebo achieving NASH Resolution with no worsening of fibrosis

120mg dose : ELAFIBRANOR  19,2% vs  PLACEBO 14,7%  p=0,0659


The published results on secondary outcomes are :

Proportion of Elafibranor treated patients relative to placebo achieving improvement of fibrosis:

120mg dose : ELAFIBRANOR  24,5% vs  PLACEBO 22,4%  p=0,44



 

ANALYSIS

First Endpoint - NASH REVERSION

The first endpoint is not reached and compromise the future of NASH treatment alone for GENFIT.

The high results of reversion in placebo arm  ( never seen in a trial)  is very high and can explain the failure of the trial

Secondary Outcomes - NASH fibrosis

This outcome is also not reached 

again, the high results ( never seen in a trial)  of fibrosis improvement in placebo arm is very high and can explain the failure of the trial

Adverse effects

no serious adverse effects 


CONCLUSION


Despite our expectations GENFIT didn’t reach success in their Phase 3 in NASH!


The valuation of the company will now rely on the potential PBC market and the NIS4 biomarker diagnosis 

GENFIT would still have the potential revenue from screening tests as estimated in the previous scenario and a potential of nearly $800,000 in the PBC as of 2024/2025 because they could then position themselves on a high selling price in the PBC.

Estimated possible average annual revenues from 2021 to 2023: $500 million

Estimated possible average annual revenues from 2024 /2025 onwards: $1200 million stable



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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