Therapy Trends KOL Insight: Nonalcoholic Steatohepatitis (NASH) [2019]

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Publication Date:
May 2019
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Are dedicated drug therapies on the way for NASH?

NASH presents a growing health challenge worldwide, particularly as rates of obesity and diabetes spiral. To date, though, there are no drug treatments approved specifically for the disease. Several novel therapies are moving through the mid- to late-stage clinical development. Which of these candidates have the best chance of reaching the market? And how will they be positioned once they get there? Learn how KOLs view the NASH market to come in NASH: KOL Insight (2018)

Twelve US and European KOLs provide candid insightson 20 experimental therapies targeting various aspects of the disease.

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Top takeaways

  • Will Intercept’s obeticholic acid be the first drug to market in NASH? The Phase III REGENERATE trial has delivered encouraging results, even without NASH resolution.  But are pruritus and pricing going to restrict uptake?
  • How do KOLs rate the next generation of FXR agonists? Are drug candidates fromEnanta, Gilead and Novartis sufficiently differentiated, and do they present a serious challenge to obeticholic acid?
  • What does Genfit’s elafibranor have to offer? How do KOLs see the drug’s prospects in the Phase III RESOLVE-IT trial and where might elafibranor fit in the NASH treatment paradigm?
  • Will dual PPAR targeting do the trick for Zydus’ saroglitazar? What outcomes are KOLs expecting from thePhase III and Phase II EVIDENCES trials in India and the US?
  • Is Inventiva’s pan-PPAR approach with lanifibranor the best option for NASH? How do KOLs see the Phase IIb NATIVE study coming out?
  • Does Gilead’s selonsertib have any prospects following its STELLAR trial setbacks?  Are KOLs surprised by the STELLAR outcomes and do they see a future for selonsertib in combination?
  • How do KOLs see the Phase IIb ENCORE trials for emricasan panning out? Is caspase inhibition the way to go in NASH, or will off-target effects prove a barrier to use?
  • How do KOLs view VAP-1 inhibition as a targeting mechanism for NASH? How much promise has Boehringer Ingelheim’s BI 1467335 shown in Phase II development?
  • Can Tobria’s cenicriviroc pull through in the Phase III AURORA trial following mixed results in Phase II? Is the drug’s best bet as a combination therapy for advanced NASH?
  • What do KOLs feel about targeting of liver triglycerides with Galmed’s Aramchol? Are these effects likely to translate into NASH resolution?
  • Are the best prospects for Gilead’s GS-0976 in combination? Could raised triglycerides in Phase II be a barrier to further development?
  • Can Novo Nordisk’s semaglutide find a place as a NASH treatment? Will the drug be confined to diabetics with NASH, and could injections be a disincentive to use?
  • What are KOLs’ expectations for FGFR inhibitors in NASH? BMS-986036 (BMS) and NGM282 (NGM Biopharma) are competing in this space. Which candidate holds the most promise?
  • How do KOLs view other novel agents such as Madrigal’s MGL-3196, Can-Fite’s Namodenoson or Immuron’s IMM-124E? Where might they sit in a future treatment algorithm for NASH?
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“There are so many different companies going after so many different pathways or targets within the pathway, right to end-stage for the disease. This is a lot of money. There's also an enormous amount of uncertainty and of development that still has to be done.”
US Key Opinion Leader

Sample of therapies covered

Late-stage Pipeline Therapies

  • obeticholic acid (Ocaliva; Intercept Pharmaceuticals)
  • elafibranor (Genfit Pharmaceuticals)
  • selonsertib (Gilead Sciences)
  • cenicriviroc (Allergan/Tobira Therapeutics)
  • saroglitazar (Zydus Cadila)

Mid-stage Pipeline Therapies

  • EDP 305 (Enanta Pharmaceuticals)
  • GS-9674 (Gilead Sciences)
  • Tropifexor (Novartis/Allergan)
  • Lanifibranor (Inventiva Pharma)
  • Emricasan (Conatus/Idun/Novartis)
  • BI 1467335 (Boehringer Ingelheim)
  • Aramchol (Galmed Pharmaceuticals)
  • GS-0976 (Gilead Sciences)
  • NGM 282 (NGM Biopharmaceuticals
  • Pegbelfermin (Bristol-Myers Squibb)
  • Semaglutide (Novo Nordisk) 
  • MGL 3196 (Madrigal Pharmaceuticals)
  • Namodenoson (Can-Fite BioPharma) 
  • IMM 124E (Immuron)

KOLs interviewed

KOLs from North America

  • Dr Naim Alkhouri, MD; Staff Physician, Digestive Disease Institute and Cleveland Clinic’s Children Hospital, Cleveland, OH
  • Prof Kenneth Cusi, MD, FACP, FACE; Professor of Medicine, Chief, Endocrinology, Diabetes & Metabolism, The University of Florida, Gainesville, FL
  • Prof Joel E. Lavine, MD, PhD; Chief of the Division of Pediatric Gastroenterology, Hepatology and Nutrition, Morgan Stanley Children's Hospital and Columbia University Medical Center, New York City, NY
  • Prof Brent A. Neuschwander-Tetri, MD, FACP, FACG, AGAF; Director, Division of Gastroenterology and Hepatology and Professor of Internal Medicine, Saint Louis University School of Medicine, St Louis, MO
  • Prof Philip Rosenthal, MD; Director of Pediatric Hepatology, University of California, San Francisco (UCSF), San Francisco, CA
  • Dr Robert Wong, MD, MS; Assistant Clinical Professor at UCSF, Gastroenterology and Hepatology Faculty, San Francisco, CA

KOLs from Europe

  • Dr Stefano Bellentani, MD, PhD; Gastroenterologist at Azienda USL di Modena, Modena, Italy
  • Dr Pinelopi Manousou, MD, PhD; Consultant Hepatologist at St Mary's Hospital, Imperial College London, London, UK
  • Prof Phillip Newsome, MD; Professor of Experimental Hepatology, Director of the Centre for Liver Research and Clinical Director of the Birmingham University Stem Cell Centre, Birmingham, UK
  • Prof Vlad Ratziu, MD, PhD; Professor of Hepatology, Université Pierre et Marie Curie and the Hôpital Pitié-Salpêtrière Medical School, Paris, France
  • Two anonymous German KOLs, Prof. Dr. med.Professors of Hepatology and Director of Liver Research Center at leading teaching hospitals in Germany

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