FGF21, A HORMONE MARKER FOR NASH RESPONDERS (by Albert Wright) 


by Albert Wright  PhD, a retired British research scientist with investments in life science and biotech companies. His approach is to try to understand the complexe science underlying the development of biotech companies and to make this information available to readers in a form that they can most easily understand. In some cases the science is new to him and requires considerable research before publishing an article. Please fell free to contact him on wriga38@gmail.com.



FGF21, A HORMONE MARKER FOR NASH RESPONDERS

In a scientific publication at the recent AASLD liver meeting in San Franciso, Genfit published data confirming that the hormone FGF21 clearly distinguished between responders and non responders of untreated Nash patients to Elafibranor in the Golden phase IIB study.

This document published on the Genfit web site on the Elafibranor page entitled :

 “THE HEPATIC AND EXTRA-HEPATIC PROFILE OF RESOLUTION OF STEATOHEPATITIS INDUCED BY GFT-505 (ELAFIBRANOR) »



This scientific poster provides a mass of information on so-called Responders and Non-responders to Elafibranor.

The key data can be found on column 3 of the poster with the key phrase :

In the Phase IIB trial, the baseline FGF21 level was 2-fold lower in G120-Responders vs G120-Non-Responders, the difference being highly significant (p<0.001).

The p value of <0,001 is impressive meaning that this is a very specific marker for responders.

FGF21

The hormone FGF21 regulates carbohydrate and lipid homeostasis as well as body weight, and increasing FGF21 improves metabolic abnormalities associated with obesity and diabetes. FGF21 is thought to act on its target tissues, including liver and adipose tissue, to improve insulin sensitivity and reduce adiposity. FGF21 appears to be primarily produced by the liver, where its expression is partially under the control of the transcription factor PPARα. FGF21 expression is also induced by endogenous PPARα ligands such as fatty acids. Brice Emanuelli et al,

 http://www.jci.org/articles/view/67353).

FGF21 has a similar action to that of PPARa and is very likely activated by Elafibranor. It may therefore be surprising to find that FGF21 was higher in G-120 Non responders than in Responders.

One explanation may be that Non-responder patients have developed resistance to the hormone FGF21 just as diabetic patients have developed resistance to insulin. If this is true then non-responders may require a higher level of expression of FGF21 to reverse Nash. This may explain the slower response to Elafibranor for these patients even though the levels of FGF21 increase to practically the same values in both groups.  During treatment with Elafibranor, the FGF21 increases two-fold in Responders compared to Non-responders.

Whatever the explanation, Genfit has clearly identified a very precise marker for the identification of Responding and Non-responding patients, in addition to Genfit's markers for the classification of Nash. I have no doubt that Genfit will use this hormone marker for identification of patients prior to the forthcoming Phase III trial and for the treatment of patients once Elafibranor is marketed.


Albert Wright PhD, November 2015

https://fr.scribd.com/doc/291207296/FGF21-A-Precise-Hormone-Marker-for-Nash-Responders



Disclaimer

This document contains interpretations and extrapolations that are entirely the work of the author and may or may not be close to the real situation. They are however based on referenced published data and analysed in good faith according to the author's experience as a scientific researcher and author. The author invites the reader to make his own research and interpretation and to draw his own conclusions. The author is open to modification of this text after discussion with the reader. Please fell free to contact him on wriga38@gmail.com

 

The author is a small shareholder in Genfit.



NOW HAVE A LOOK ON NASH, MARKET, SEGMENTATION, INTERCEPT, GALMED,GILEAD,GALECTIN, ETC



Share on StockTwits

WWW.NASHBIOTECHS.COM  -  Copyright G DIVRY 2015-2016