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Expert Interview

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

Dissecting the latest Phase 3 data on OCA for NASH released on Feb 19th

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

Who's the expert?

Name: Dr Joel E. Lavine - MD

Institution: Columbia University

  • Chief of Gastroenterology, Hepatology and Nutrition at Columbia University Medical Center & the Vice-Chairman for Research in the Department of Pediatrics.
  • Currently manages 100 patients with NASH.
  • Chair of the Steering Committee of the Nonalcoholic Steatohepatitis Clinical Research Network for the NIDDK for the past 15 years; Led major clinical research trials on treatment of NASH published in the Lancet, Journal of the American Medical Association and the New England Journal of Medicine.

Interview Questions
Q1.

Please describe your clinical practice and experience with NASH/OCA.

Added By: joe_mccann
Q2.

What is your high level reaction to the Phase 3 OCA study results? link

Added By: joe_mccann
Q3.

What do you think of the pruritus side effect? Do you think it could be better managed outside of a clinical trial protocol? 

The most common adverse event reported was dose-related pruritus (19% in placebo, 28% in OCA 10 mg and 51% in OCA 25 mg). The large majority of pruritus events were mild to moderate, with severe pruritus occurring in a small number of patients (<1% in placebo, <1% in OCA 10 mg and 5% in OCA 25 mg). A higher incidence of pruritus associated treatment discontinuation was observed for OCA 25 mg (<1% in placebo, <1% in OCA 10 mg and 9% in OCA 25 mg). According to the clinical study protocol, investigator assessed severe pruritus mandated treatment discontinuation.

Added By: joe_mccann
Q4.

Please add CBAY to list of companies discussed

Added By: drsug
Q5.

On Behalf of a client: Are there NASH patients warehoused for the launch?

Added By: joe_mccann
Q6.

On behalf of a client: Thoughts on the fibrosis effect size in REGENERATE, particularly given it is an ITT analysis and not a responder analysis?

Added By: joe_mccann
Q7.

On behalf of a client: How onerous will the physician education be?

Added By: joe_mccann
Q8.

On behalf of a client: Would he/she like to see future trials ran against Ocaliva or fine with placebo-controlled?

Added By: joe_mccann
Q9.

How important is fibrosis benefit versus other end points such as NASH resolution or even biomarkers such as MRI-PDFF?

Added By: joe_mccann
Q10.

On behalf of a client: Thoughts on other mechanisms such was FGF21, FGF19, PPAR, and THR? How about specifically their ability to improve fibrosis. Any other mechanisms of interest?

Added By: joe_mccann
Q11.

On behalf of a client:

  • What does 11% pbo-adj. efficacy mean to you?
  • Same for 32% pruritus?
    • 9% pruritus DC rate?!
    • Is OCA-induced pruritus truly manageable?
  • Does s/he buy the story that pruritus can ameliorate over time? If so, how many can tolerate in real world since we know trials are very different?
    • How does a patient handle this in the real world?
  • Thoughts on LDL increase (remember we don’t know full statin utilization plan until EASL)
  • 3% gallstone rate did not exist in Ph2 FLINT.
    • Thoughts?
    • Why might this be occurring?
    • Do you see gallstones in your NASH patients naturally?
  •  What is the commercial viability of this compound?
    •   How does this change with the thinking ICPT may be the only NASH F2-F3 treatment for 2-3 years?
    • How much does being first matter (can mention statins as an example with atorv taking the cake though was not first) in NASH?
  •  What are your thoughts on a OCA-bezafibrate NASH FDC combo?

Added By: joe_mccann
Q12.

On behalf of a client: Thoughts on the pruritis? Can it be managed? Would he/she use drug holidays or dose titration? Thoughts on the pruritis data given placebo had 19% pruritis rates, seems like patients enrolled looking for the ae?

Added By: joe_mccann
Q13.

On behalf of a client: What is his/her expectation for uptake of Ocaliva? How will he/she use Ocaliva in his/her practice?

Added By: joe_mccann
Q14.

On behalf of a client: Does he/she have any concerns with Ocaliva’s liver safety in light of the update yesterday that the Placebo arm had 3 cases of Hy’s Law vs 2 on low dose vs 1 on high dose?

Added By: joe_mccann
Q15.

On behalf of a client: How would he/she hypothetical prescribe Ocaliva vs maybe a future approved THR that has no fibrosis benefit, only on NASH resolution?

Added By: joe_mccann

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