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Expert Interview

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

Discussing Primary biliary cholangitis (PBC) and Primary sclerosing cholangitis (PSC) treatment options in development

Ticker(s): ICPT, CBAY

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.

Please describe your practice and involvement in drug development for PSC & PBC.

Added By: joe_mccann
Q2.

How credible is alkaline phosphatase (AP) as a clinical endpoint both for practicing docs and as a part of clinical trial designs when treating and pursuing PBC and PSC?

  • Long standing and sometimes contentious debate as to whether absolute AP levels and trending AP levels are reliable markers from both a sensitivity and specificity perspective in the setting of chronic cholestatic liver diseases. Skeptics sense lowering AP levels in PSC are actually masking the continued progression of the disease – a false positive?

Added By: joe_mccann
Q3.

How promising is the FXR agonist approach in the setting of both PBC and PSC?

Added By: joe_mccann
Q4.

Considering the heterogeneous landscape of gastrointestinal diseases and the liver, how does a hepatologist approach chronic liver diseases of a non-viral nature with any degree of confidence? Or, is hepatology in the setting of chronic cholestatic liver diseases still largely a …"monitor the disease and treat the symptoms" paradigm?

Added By: joe_mccann
Q5.

What does the current landscape look like in terms of diagnostic tools for PBC and PSC and how do those tools inform the treatment decision relative to treatment protocols currently under clinical investigation? IOW, if a patient presents with elevated LFTs, a histologically and radiographically confirmed fibrosis score of F2 but otherwise asymptomatic in the setting of either PBC or PSC, what would you as a treating physician like to have access to considering the options currently under investigation.

Added By: joe_mccann
Q6.

How does Intercept’s Obetacholic acid perform in the setting of PBC?

Added By: joe_mccann
Q7.

Specifically, what are your thoughts on the PPAR & agonist platform that is currently the focus of companies like Cymabay?

Added By: joe_mccann
Q8.

What insights, if any, were gained from Gilead’s study of their monoclonal antibody against LOXL2 in the setting of PSC and NASH?

Added By: joe_mccann

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