Nonalcoholic Steatohepatitis: KOL Insight

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1 unit
Publication Date:
March 2015
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Why This Report is Essential

KOL Views Covered

Expect a revolution in the treatment of nonalcoholic steatohepatitis (NASH) as a number of new therapies compete to become the first approved treatment for a disease that has high unmet clinical need. Nonalcoholic Steatohepatitis: KOL Insight reveals the critical views of US and European KOLs whose insights hold key lessons for pharma. Gain insights on products in the pipeline and how they could revolutionise the treatment algorithm.

Among the pipeline products analysed in this report is Intercept's/Dainippon Sumitomo Pharm's FXR agonist, obeticholic acid, Genfit's PPAR alpha/delta agonist, GFT505 and Gilead's simtuzumab. Others vying for market voice include Tobira Therapeutics's dual CCR2/CCR5 antagonist, cenicriviroc (TBR-652) and in the paediatric sector, Raptor Pharmaceuticals' delayed-release cysteamine bitartrate.

The upcoming products vary in their effectiveness in resolving the steatohepatitis and controlling fibrosis associated with NASH. Combination therapy is likely to shape the treatment paradigm in the future, as none offer a single solution.

Nonalcoholic Steatohepatitis: KOL Insight gives exclusive insights on what leading NASH specialists think about the emerging clinical benefits and disadvantages of key pipeline programmes and what will influence prescribing decisions. In addition, specialists voice their opinions on optimal clinical trial designs, including endpoint selection, which could help clarify future treatment decisions.

Current Treatments
  • Vitamin E
  • Actos (pioglitazone; Takeda)
Pipeline Drugs
  • Obeticholic acid (INT-747; Intercept/Dainippon Sumitomo Pharma)
  • GFT505 (Genfit)
  • Simtuzumab (GS-6624; Gilead)
  • Cenicriviroc (TBR-652, Tobira Therapeutics)
  • Delayed-release cysteamine bitartrate (RP103; Raptor Pharmaceutical)
  • Aramchol (Galmed Pharmaceuticals)
  • Emricasan (IDN-6556; Conatus Pharmaceuticals)
  • Victoza/Saxenda (liraglutide; Novo Nordisk)


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Key Benefits

  • Understand the clinical insights of current treatment strategies and formulate effective strategies for new product positioning and clinician communication.
  • Map new treatment options to the NASH spectrum, including patient sub groups, in preparation for market planning activities.
  • Identify what emerging product attributes and patient characteristics KOLs think will be most important in terms of influencing prescribing decisions.
  • Discover which clinical trials, including designs and endpoints, the KOLs believe will have a significant impact on future treatment decisions and their likely outcomes.
  • Evaluate the evolving NASH competitive landscape to get an edge on potential licensing opportunities in the future.

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Get Answers to Critical Questions

  • Intercept's/Dainippon Sumitomo Pharma's obeticholic acid addresses NASH on many levels but how will adverse reactions impact its approval and the future use of the drug?
  • What key clinical differentiators could Genfit exploit for GFT505, its PPAR alpha/delta agonist?
  • What pricing strategy should Gilead consider for anti- lysyl oxidase-like-2 (LOXL2) mAb, simtuzumab?
  • Preliminary results for Tobira's dual CCR2/CCR5 antagonist, cenicriviroc, are seen as encouraging by KOLs, but what do KOLs think are the best combination approaches with this product?
  • Raptor Pharmaceuticals' RP103 is expected to be first-to-market for paediatric NASH, but cost and competition from other therapies which gain the same indication remain challenges for the future; how might the company best meet these?
  • What role will biomarkers play in shaping the NASH treatment landscape?
  • The use of combination therapy looks set to deliver the best outcomes for patients with NASH, but which products and MOAs are looking compatible at this stage?

Top Takeaways

  • Hear the detailed opinions of leading front line clinicians on current and future treatments for NASH, and what they see as the critical advantages/disadvantages affecting their decision to use.
  • Understand important clinical and market factors that will shape the NASH sector and identify key areas for strategic and tactical action.
  • Benchmark current thinking on how the new therapies will fit into the treatment paradigm.
  • Review KOL attitudes to important clinical trials such as FLINT, GOLDEN, CENTAUR, ORION, CyNCH, and LEAN.

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Key Opinion Leaders

North America

  • Scott L. Friedman, Professor, Icahn School of Medicine at Mount Sinai
  • Brent A. Neuschwander-Tetri, Professor, Saint Louis University School of Medicine
  • Stephen A. Harrison, University of Texas Health Science Center in San Antonio and Brooke Army Medical Center, Fort Sam Houston, Texas
  • Philip Rosenthal, Professor, University of California, San Francisco
  • Mary Rinella, Northwestern University Feinberg School of Medicine
  • Joel Lavine, Morgan Stanley Children's Hospital and Columbia University Medical Center


  • Vlad Ratziu, Professor, Université Pierre et Marie Curie and the Hôpital Pitié-Salpêtrière Medical School in Paris
  • Elisabetta Bugianesi, S. Giovanni Battista Hospital, University of Torino
  • Giulo Marchesini Reggiani, Professor, University of Bologna
  • Fabio Marra, University of Florence
  • Guruprasad P. Aithal, Nottingham Digestive Diseases Centre, University of Nottingham
  • Anonymous German KOL

Update Bulletins Offer Ongoing Benefits

The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord’s guarantee to keep Therapy Trends clients up to date with Update Bulletins offers a real commercial advantage.

Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.

  • Your Therapy Trends Report purchase entitles you to receive three Update Bulletins, which are published approximately every three months for 12 months following the report's publication date, March 2015.
  • You will receive a copy of each Update Bulletin once available, which are issued each quarter after the publication date.

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Therapy Trends reports deliver critical and unbiased intelligence derived from in-depth interviews with the world’s foremost thought leaders on the current and future treatment landscapes in major disease areas. Research is focused on the major battlegrounds for market share and answers critical business questions about potential product positioning and competitiveness. Through continuous monitoring and frequent re-engagement with stakeholders, the FirstWord Therapy Trends analyst team delivers quarterly updates with each report ensuring insights remain current and relevant.