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Discussing the NASH Drug Development Landscape: How Big is the Opportunity and How Do the Major Drugs in Development Stack Up? With a specific focus on elafibranor.Ticker(s): GNFT.PA, AGN, GILD, SHPG, GNFTF, ICPT
Name: Dr Stephen Harrison - MD
Institution: University of Oxford (UK) and Pinnacle Clinical Research (US)
- Medical Director of Pinnacle Clinical Research.
- Leading authority on liver diseases.
- Peer-reviewer for over 20 medical journals and internationally known for studies in hepatitis C and non-alcoholic fatty liver disease with over 150 peer reviewed publications in these fields.
Please describe your background in NASH drug development and clinical practice.Added By: joe_mccann
Can you walk us through a typical NASH patient's journey to the extent that there is a 'typical'. How do they typically present, what are first and second line treatments? How successful are treatments to address NASH now and what other co-morbidities do they typically have?Added By: joe_mccann
How aggressively are patients diagnosed with NASH currently? Are a large number of patients identified?Added By: joe_mccann
At a high level how excited are you about NASH drugs that are in development, particularly in Phase 3 trials?Added By: joe_mccann
GENFIT, and subsequently other programs, are using the consensus definition of "NASH resolution" as endpoint. What is the relevance of this endpoint?Added By: joe_mccann
Focusing on Elafibranor's potential, what are your thoughts on the RESOLVE-IT trial and the Phase 2 results that have been publicly disclosed?
Can you walk us through the cardiometabolic risk benefits elafibranor has shown in the clinic, and how that differentiates from other programs out there?
When the FDA finally approves the first therapies for NASH, what sort of launch trajectory would you anticipate? What approved drugs in liver diseases or other diseases might be a good comp for us to look at?Added By: joe_mccann
Given that NASH is both a chronic and an asymptomatic condition, how does the safety and tolerability profile of the different programs position for monotherapy and combination therapies?
Given the limits on diagnostics, how are we going to find all those patients needed for all the NASH trials that are forthcoming?Added By: user4ed9acbc
Intercept Pharmaceuticals modified their trial size from 2000 to 500 so that they could get results sooner. Part of the rationale was to also try to reduce the incidents of the side effects of pruitis. In Intercept's earlier trial the 10 mg arm showed no statistical relevance over the control. By diluting a study that was designed for 2000 patients isn't there a real risk that they don't meet their endpoint?Added By: user41f141e7
There are 3 ways to tackle NASH Fat, Inflammation, and Ballooning. The FDA has made it clear that by reducing Fat alone in not the pathway to approval. Where is the FDA's thinking on approval endpoints in NASH currently?Added By: user41f141e7
The FXR Agonist, the PPAR Agonist, CCR2+CCR5 , and the Galectin-3 are all being developed for NASH. Which do you feel holds the most promise?Added By: user41f141e7
We've seen several abstracts and presentations from genfit on their program in non-invasive diagnostic. How relevant is the approach and what impact is expected in the NASH field?
What about the Methacin Breath test that showed a correlation to HVPG?Added By: user41f141e7
Did Dr. Harrison discuss combination therapy. Currently, OCA is approved for use in combination w/Urso or when Urso has failed in PBC. Will these new therapies be used in combo?Added By: user4ca005c0
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