Genfit - die Alternative zu Intercept? (Seite 16)

[question-mark]

Antwort auf Beitrag Nr.: 50.771.100 von liolio am 04.10.15 15:53:40

Salut Liolio,

ich habe gesehen, dass Genfit die neue Studie gestartet hat, verstehe ich das richtig, dass nach 900 Patienten eine Zwischenauswertung erfolgt, die schon zu Zulassung herangezogen werden kann? Wahrscheinlich abhängig von der erzielten efficacy?
Weisst du, welcher Zeithorizont dafür nötig sein wird?

Danke dass du hier ab und an postest, und uns (falls NASH noch andere interessiert) auf dem Laufenden hältst.

cheers QM

[liolio]

105 : An international, phase 2 randomized controlled trial of the dual PPAR α-δ agonist GFT505 in adult patients with NASH
Conclusion. In NASH patients 120 mg daily of GFT505 induced histological improvement and resolution of NASH, significantly more often than PLB. The excellent safety and tolerability and the improvement in cardiometabolic risk profile makes GFT505 an ideal drug can- didate to be tested in phase 3 trials


162 : Beneficial effects of the dual PPAR α-δ agonist, GFT505, on hepatic and cardiometabolic markers in adult NASH patients.
Conclusion. GFT505 at 120 mg daily shows consistent cardio-metabolic effects in NASH across the whole spectrum of histological severity. It also improved non-invasive scores of steatosis and fibrosis. The cardioprotective profile of GFT505 could be highly beneficial for the treatment of NASH in light of the increased cardiovascular mortality in this condition.

974 : GFT505 (ELAFIBRANOR) prevents nonalcoholic steato- hepatitis (NASH), hepatic fibrosis and hepatocarcinoma in a new disease model

Conclusion: GFT505 prevented NASH, fibrosis, cirrhosis and pre-neoplastic lesion development in this novel NASH model. Since the effect of GFT505 on hepatic steatosis was rather modest in this particular model, this study demonstrates that the antifibrotic activity of GFT505 can be dissociated from its hypolipidemic efficacy.

2145 : The hepatic and extra-hepatic profile of resolution of steatohepatitis induced by GFT-505

CONCLUSIONS: Resolution of SH is associated with an improvement in all histological fea- tures of NASH, and most importantly with an improvement of fibrosis. Treatment with GFT505 shows significant additional improvements in responders, notably on cardiometabolic mark- ers (lipids, glucose homeostasis, inflammation) and liver mark- ers

[liolio]

GENFIT ANNOUNCES ELAFIBRANOR PRESENTATIONS AND PRESIDENTIAL PLENARY AT THE 2015 AASLD ANNUAL MEETING
 The results of the GOLDEN-505 phase 2b study of Elafibranor in NASH have been selected for an exclusive oral presentation during the Presidential Plenary session.
 Additional data from the Phase 2b study will be described in oral presentations as well as in a poster session.


PRESIDENTIAL PLENARY !!

[liolio]

Antwort auf Beitrag Nr.: 50.629.816 von question-mark am 15.09.15 16:03:10

Zitat von question-mark: merci liolio, das hört sich gut an und der Kurs zieht mächtig los.

Die biomarker sind ja das zweite Standbein von genfit, wird wieder interessanter.

Biomarker sind zunächst ein enormer Vorteil von Genfit ggü Intercept, für die Wahl der Patienten !

[liolio]

imho, nicht amha :-)

[liolio]

Hallo qm :-)


Présentation Morgan Stanley Conference
15 septembre, 2015

http://www.genfit.com/wp-content/uploads/2015/09/2015.09.15-…

GENFIT wird ein Vergleich von FLINT vs GOLDEN und GFT vs OCA zeigen...

1/ safety
2/ phase 3 deutlich als genehmigt gezeigt




Comparison GOLDEN/FLINT/PIVENS Results in the NAS ≥4 Phase 3 Target Population
• Patients with a NAS score ≥4
• The target population for treatment, according to KOLs
• Inclusion criteria in previous trials
• Corresponds to the target population to be included in Phase 3 studies with GFT505
Comparison GOLDEN/FLINT/PIVENS Conclusions (NAS ≥4 Phase 3 Target Population)

• Efficacy comparable to OCA on NASH histological end-points in the Phase 3 target population (NAS score ≥4)
• GFT505 has a beneficial cardiometabolic profile
• GFT505 has a favorable safety & tolerability profile


Die Wahrheit wird endlich auftauchen.
Grosser Potential amha

:-)

[question-mark]

merci liolio, das hört sich gut an und der Kurs zieht mächtig los.

Die biomarker sind ja das zweite Standbein von genfit, wird wieder interessanter.

[liolio]

Raptors ; out of Nash
ICPT: phase 3 5 Jahre
Genfit : sehr gute Beziheungen mit FDA, diagnostic, keine Seiteneffekt


(ich habe Genfit Aktien seit Ende 2011)

[liolio]

GENFIT ANNOUNCES POSITIVE RESULTS FROM PROPRIETARY NASH BIOMARKER PROGRAM
 GENFIT has designed a diagnostic tool – as an alternative to invasive liver biopsy – to identify NASH patients that deserve to be treated, according to the consensual definition agreed between experts and regulatory agencies.
 The diagnostic tool requires a simple blood sample and is based on algorithms including a new type of NASH biomarkers: circulating miRNAs.
 GENFIT has filed new patents and is building up a partnering program to make a diagnosis kit available at the time of commercialization of anti-NASH drugs.
Lille (France), Boston (Massachusetts, United States), September 15th, 2015 – GENFIT (Euronext: GNFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces the development of a new reliable and non-invasive diagnostic method, based on the measurement of a novel type of blood biomarker: small non-coding RNA, or miRNA. The algorithm developed enables the identification of NASH patients that should be treated with Elafibranor (GFT505) or any other appropriate drug.
In terms of public health, the management of the NASH epidemic is a priority. However, NASH is currently under-diagnosed since: i) NASH is a silent, asymptomatic disease, ii) NASH diagnosis necessitates an invasive procedure, the liver biopsy, that can only be performed by an experienced person, iii) there is currently no approved medicine for this indication.
The efficient management of the NASH patient population thus requires new, non-invasive, diagnostic tools, that are simple, rapid, reliable, and can be widely distributed, in order to screen and detect NASH patients that should be treated.

[Jagubert]

Antwort auf Beitrag Nr.: 50.605.199 von question-mark am 11.09.15 14:47:26

Gestern ist Raptor mit seiner NASH-Studie in Phase IIb gescheitert.