Genfit And GenKyoTex In PBC: What To Expect In Phase 3 [Seeking Alpha]
GENFIT S.A. - American Depositary Shares (GNFT)
Company Research
Source: Seeking Alpha
Genfit And GenKyoTex In PBC: What To Expect In Phase 3 Summary Genfit and GenKyoTex are both small market-cap biopharmas with a different but unique therapeutic approach to Cholestatic Liver Disease, PBC. Elafibranor developed by Genfit was associated with a significant decrease in levels of the cholestatic biomarker, alkaline phosphatase, in PBC patients at 12 weeks without worsening of pruritus. Similarly, Setanaxib, a selective dual NOX1/4 inhibitor in clinical development for PBC by GenKyoTex, was associated with anti-fibrotic and anti-cholestasis benefits at 24 weeks with no safety signals. Both companies have each reported plans for a Phase 3 PBC study for their respective drug candidates. I provide an overview on what I would expect from these planned studies. Introduction For two decades, the scientific advance of investigative drug candidates for PBC into clinical development seemed like an illusion. FDA approval of obeticholic acid (i.e. ocaliva) in 2016 as a breakthrough th
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- Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus [Yahoo! Finance]Yahoo! Finance
- GENFIT Announces Corporate Updates and Upcoming Participation at The Liver Meeting® 2024 [Yahoo! Finance]Yahoo! Finance
- GENFIT Announces Corporate Updates and Upcoming Participation at The Liver Meeting® 2024GlobeNewswire
- GENFIT Reports Third Quarter 2024 Financial Information [Yahoo! Finance]Yahoo! Finance
- GENFIT Reports Third Quarter 2024 Financial InformationGlobeNewswire