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Making sense of the NASH market and where the leading development compounds stand after data presented at EASL 2019

Ticker(s): ICPT, AGN, MDGL, VKTX, GILD

Who's the expert?

Name: Dr Naim Alkhouri - MD

Institution: Texas Liver Institute

  • Director of the Metabolic Health Center at the Texas Liver Institute in San Antonio & Associate Professor of Medicine at the University of Texas (UT) Health San Antonio.   
  • Fellowship trained (Adult Transplant Hepatology) at the Cleveland Clinic.
  • Specializes in nonalcoholic fatty liver disease, viral hepatitis, autoimmune hepatitis, alpha 1 antitrypsin deficiency, and liver transplantation; has over 100 publications and presents his work at both national and international medical conferences. 

Interview Questions
Q1.

Questions to come. Join & add your own!

Added By: c_admin
Q2.

How does Pruritus evolve with OCA overtime (w/ or w/o concomitant therapy intervention) in different patient segments and its impact on patients dropout rate ? 

Added By: cuicas
Q3.

Liver biopsy leads to quite a lot o screening failure in NASH clinical trials. What role do you see for a LDT (Lab dev test) in clinical trials, like the one Labcorp is now rolling out in clinical research, leveraging the work done by Genfit?

Added By: user8ad2729b
Q4.

Given the effect of OCA on LDL, do you foresee that some patients would not be eligible to receive the treatment (typically patients with cardiovascular diseases)? In general what would the OCA patient profile look like?

Added By: user8ad2729b
Q5.

Could you give us your general impressions about maybe some of the trends or the signals related to NASH that you're observing and hearing about at EASL.

Added By: c_admin
Q6.

Can you offer some impressions on Viking's approach to treating NASH with regard to their drug 2809?

Added By: c_admin
Q7.

What were your overall impressions of the data that came out of the REGENERATE study?

Added By: c_admin
Q8.

To better understand the pruritus that's been observed in this study; when you see patients and theyexperience this side effect, what is it like? How do they tolerate it? 

Added By: c_admin
Q9.

So given the effect of OCA on LDL, do you foresee that some patients would not be eligible to receive that treatment (for example patients with cardiovascular disease)?  In general, what would the OCA patient profile look like if the drug is approved?

Added By: c_admin
Q10.

What about the liver biopsy requirement? Do you see that being a requirement for diagnosis and for evaluating treatment? What impact would that have in a commercial setting?

Added By: c_admin
Q11.

Obviously, we'll have to wait a while for the outcome of the Madrigal phase three study, but if you have an endpoint or we get to the end and we see NASH resolution, but we really don't see any benefit on fibrosis, how would you interpret data like that? Would that be a disappointment? How wouldyou feel about that?

Added By: c_admin
Q12.

Do you have a prediction on the outcome of Genfit's P3 study for elafibranor?

Added By: c_admin
Q13.

There was some controversy when they presented data, the per-protocol analysis on the efficacy side. How do you interpret the per-protocol, which showed slightly more efficacy than they showed on the ITT? 

Added By: c_admin
Q14.

Looking at your own practice and the patients that you see, if you had to provide a rough estimate, how many patients do you think you would recommend try this medicine, OCA, if it was approved?

Added By: c_admin
Q15.

What are your thoughts about similarities/differences between the Viking compound and the Madrigal drug?

Added By: c_admin

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