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Expert Interview

Slingshot members are talking to an expert! The topic is:

Nonalcoholic Steatohepatitis (NASH): What’s the Market Opportunity and Who are the Major Players?

Ticker(s): AGN, ICPT, GNFTF, GLMD, CNAT, GILD

Who's the expert?

Name: Dr Joseph Lim - MD

Institution: Yale University

  • Academic hepatologist, Associate Professor of Medicine (Digestive Diseases) and Director, Yale Viral Hepatitis Program.
  • Treats patients with chronic liver diseases including the entire spectrum from cirrhosis, liver failure, and post-transplant; Approximately 5-10% of his patients have chronic pruritus symptoms, 200 patients with biopsy-proven NASH and a larger cohort of NAFLD, and 70 patients with PBC/PSC.
  • Has served on the national steering committees for large observational cohort studies for liver disease and has published over 100 papers in the area of GI and liver diseases.

Interview Questions
Q1.

What is your background treating serious liver diseases? How many patients do you treat with NASH?

Added By: kcmckee
Q2.

What current recommendations are you making to patients with NASH when there are no FDA approved treatments?

Added By: kcmckee
Q3.

NASH sounds like it is frequently left undiagnosed. Why do you think this is, and do you see this changing at all in the future? What do you think this means for the potential NASH market?

Added By: kcmckee
Q4.

Generally speaking, what categories of NASH drug do you think hold the most potential? What in the data leads you to believe these will be the most effective treatments?

Added By: kcmckee
Q5.

What are your thoughts on the NASH drugs being developed by GILD, AGN, ICPT, GLMD, GNFT, and CNAT?  Are there other major companies you think investors should keep an eye on? 

Added By: kcmckee
Q6.

Overall, what drugs do you think hold the most potential for treating NASH? Why?

Added By: kcmckee
Q7.

Some estimates have proposed a $20 billion NASH market by 2025. Does this sound plausible in your opinion?

Added By: kcmckee
Q8.

How much potential do you think NASH drugs have for treating other fatty liver diseases? Do any of the aforementioned companies have a product you think would lend itself especially well to treating other serious liver conditions?

Added By: kcmckee
Q9.

How will future therapies be spread across different call points? Will they all be prescribed by GPs? Which will likely be prescribed with a gastroenterologist or hepatologist? 

Added By: userde43a902
Q10.

Once a patient has been started on a future med, do you think it is practical (and economically feasible) to do annual / semi-annual follow-up monitoring with the traditional scanning technologies and tissue biopsy ?  Surely payers will expect long-term monitoring of patient disease progression/ regression while on therapy ? What about the potential for liquid biopsies now in research or being used in Europe?

Added By: user6f5a2920
Q11.

Is there any work going on to develop a better diagnostic test for NASH that does not require a biopsy? 

Added By: userc268134d
Q12.

Given the low rate of diagnosis of NASH and limited number of experienced investigators, enrollment of all the competing trials for these drugs is expected to be a major challenge. 
Are you aware of any companies using novel approaches to overcome this challenge, or do you have any ideas on what companies could do to successfully meet their enrollment goals? 

Added By: userd224c079
Q13.

Many laboratories are focusing on NASH induced Fibrosis (CNAT emricasan , GILEAD simtuzumab, Tobira cenicriviroc) Do you think it is logical to treat the consequences of NASH (fibrosis and cirrhosis) without treating  the cause ( metabolic NASH) ? If as seen in HEP C, a liver with less than 70% of advanced fibrosis can regenerate if the HEP C ( the cause ) is cured, do you think that a drug targeting metabolic causes of NASH could induce a fibrosis reversion ?

Added By: gdivry
Q14.

Your views on  endoglin expression and its relationship to fibrosis, and the possible use of endoglin antibodies to
reverse or stop fibrosis?

Added By: userfaa1ee0e
Q15.

Cempra recently presented some interesting preliminary data in NASH patients treated with their new antbiotic
solithromycin. Have you seen the data? Any thoughts?

Added By: userfaa1ee0e
Q16.

In many trials , serological markers were well improved as histological markers were less improved. Do you think that biopsy representing  1/50000  of the liver mass is representative of the liver state ?

Do you think that composite endpoints mixing histological and metabolic  markers could be more representatives of the liver state  ?
  

Added By: gdivry
Q17.

Over the past 18 months, leading KOLs and other NASH experts have moved away from NAS score alone (two-point improvement) endpoint .Today the two approvable surrogate endpoints for NASH are composites: 'complete resolution of steatohepatitis and no worsening of fibrosis', or 'at least one-point improvement in fibrosis with no worsening of steatohepatitis' 1 - The FLINT results were based on the NAS score two-point improvement and not on the current required endpoints for Phases 3, moreover, OCA failed to reach those endpoints in the Japanese study. Could this make difficult to OCA to reach the new endpoints in their ‘Regererate’ Study ? 2 – why many new 2b trials launched in 2016 still use NAS score two-point improvement as endpoint, is it because it is an easier endpoint to reach than the new required NASH reversion ( 0 in ballooning  and 0-1 in inflammation) .

Added By: gdivry
Q18.

More specifically, regarding the diagnosis of NASH, should we expect Fibroscan or, something like it, to become the standard of care or; will biopsy still be the final say in determining a final/confirmed NASH diagnosis?

Added By: user4ca005c0
Q19.

Do you think that taking statins could interfere or impact results in NASH trials

Added By: gdivry
Q20.

The most advanced compounds in NASH pipeline are an FXR agonist (OCA) and a PPAR alpha /delta (Elafibranor) with different targets and effects Do you think that a combo with those two drugs could be pertinent and efficient  ?

Added By: gdivry

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