Phase 3 Full Data Set Review
Second half of 2020
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Catalyst Info & Data Links
TITLE: Elafibranor in NASH - Phase 3 Full Data Set Review
ClinicalTrial.gov (NCT02704403): Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT)
WHAT IS THE NEXT CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
H2 of 2020
06-2020: Corporate Presentation (slides 6, 12, 15-18)
2016: Elafibranor, an agonist of the peroxisome proliferator− activated receptor− α and− δ, induces resolution of nonalcoholic steatohepatitis without fibrosis worsening. Gastroenterology, 150(5), 1147-1159.
Cenicriviroc - Allergan
Cotadutide - AstraZeneca
Ocaliva - Intercept Pharmaceuticals
Resmetirom - Madrigal Pharmaceuticals
Selonsertib - Gilead
Tropifexor - Novartis
~19 million NASH patients
~16 million patients with fibrosis due to NASH
~1.5M under Hep/GI care
Source - Estes, C., Razavi, H., Loomba, R., Younossi, Z., & Sanyal, A. J. (2018). Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology, 67(1), 123-133.
MECHANISM OF ACTION / RATIONALE
Elafibranor is a dual agonist of the PPARα and PPARδ. Meaning the drug candidate acts simultaneously on the two nuclear receptors, which both play an important role in numerous processes involved in the development of NASH and its co-morbidities (learn more)
Updated by HC
GNFT, Elafibranor, Non-alcoholic steatohepatitis, NASH
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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