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The first new NASH therapy is due soon: but is it safe and effective enough? How happy are KOLs with the plethora of current trials and endpoints? Which is more appealing: tackling early signs or advanced stages? With no cure in sight and issues around diagnosis, long-term safety and cost all still being hotly debated-clearly there is plenty of work to be done.
This report examines the current and emerging treatment options in detail. It covers the 9 pipeline therapies set to hit the market over the next decade, looks at how the market will be transformed as a result. Is there enough confidence for mass adoption of new drugs – or will practitioners hold back for combination therapies? Which products are the most promising? This study helps you reach your own conclusions.
“One of the biggest issues is [that] we need screening guidelines and good non-invasive ways so we can change this whole paradigm and algorithm that we use now because it’s just too invasive.”
US Key Opinion Leader
Expert insight into the NASH treatment landscape
Current treatments (off label)
Vitamin E: Has it had its day? Why are some KOLs already veering away from using Vitamin E? How does it compare to pioglitazone?
Actos (pioglitazone; Takeda): What reasons are cited for prescribing pioglitazone? Is the adverse safety profile having an impact on choice?
Obeticholic acid (OCA/Ocaliva; Intercept Pharmaceuticals) Improvements in fibrosis are promising but how concerned are KOLs about the safety profile? Can OCA hold onto its first mover advantage once other products come on stream?
Elafibranor (GFT 505) (Genfit Pharmaceuticals) Was the disappointment of the GOLDEN-505 study down to the drug or its design? Why are some KOLs still positive about the outcomes? Is elafibranor an ideal partner for OCA?
Aramchol (Galmed Pharmaceuticals) Why are KOLs wary of Aramchol as a monotherapy? Does Aramchol have a long-term role in NASH treatment?
Emricasan (IDN-6556; Conatus Pharmaceuticals) Is scepticism about emricasan’s mechanism of action widespread? How do KOLs view the potential cancer risk – and will late stage NASH patients be eligible for treatment?
Simtuzumab (GS-6624; Gilead Sciences) Will positive efficacy results cancel out concerns about the IV-administration? What are KOLs saying regarding cost, combination potential and the immunogenicity issues?
Cenicriviroc (TBR-652, Tobira Therapeutics) Do KOLs consider cenicriviroc to be a serious contender without NASH trial data? Is it too early to speculate?
Victoza/Saxenda (liraglutide; Novo Nordisk) Is liraglutide seen only as a diabetic medication or do KOLs perceive it to have potential as a NASH treatment? Why are some KOLs particularly interested?
GS-4997 (Gilead Sciences) Where in the NASH treatment algorithm is GS4997 expected to sit? Why are some KOLs actively urging caution?
BMS-986036 (Bristol-Myers Squibb; BMS) Is initial interest a precursor for eventual clinical adoption or is it simply theoretical? What are KOLs saying about the approach so far?
Trial design is an issue: KOLs want more consistent endpoints used, particularly as regulations are still evolving. How useful are the NAFLD activity score (NAS) and Hepatic Venous Pressure Gradient (HVPG) as surrogate endpoints? What outcomes will be needed for approval? And what is the one outcome KOLs agree is crucial?
Non-invasive biomarkers are a critical unmet need: With no reliable alternatives, liver biopsy is widely used. So why are KOLs voicing concerns about use during diagnosis and within trials? KOLs don’t expect non-invasive biomarkers to be widely adopted any time soon; how will that impact decision-making?
Improvement in fibrosis is a key outcome in the approval process but will take years to prove: Will KOLs embrace NASH treatments that only promise not to worsen fibrosis? Are better NAFLD activity scores (NAS) and liver enzyme improvements seen as reliable measures?
None of the pipeline therapies are ideal: KOLs are concerned about the safety and tolerability of OCA; elafibranor has prompted mixed views following the GOLDEN-505 study results; and Aramchol may not be suitable for long-term use. With no clear favourite, can prescribing trends be predicted with any confidence?
Different stages of disease being targeted: Pipeline drugs such as elafibranor and Aramchol focus on early stage NASH whereas emricasan, simtuzumab and OCA are later stage treatments. Given the numerous stages in the pathogenesis of NASH, and the range of contributory factors, is a ‘one-stop’ solution likely or even desirable? What do KOLs believe are the ideal characteristics of a novel NASH product?
Invasive testing is unpopular but necessary: Liver biopsy is still widely viewed as the gold standard – but for how long? What testing procedures do experts really need to facilitate more widespread patient screening? Why is the reliability of current screening methods, such as magnetic resonance elastography (MRE) and FibroScan, still questioned by experts, even though adoption is increasing?
Combination therapies are a compelling concept: There is no ‘magic bullet’ drug emerging from the development pipeline. KOLs agree, therefore, that the future of NASH treatment will most likely involve combination therapy. Given the timelines and the broad spectrum of symptoms, combination approaches will enable physicians to individualise treatment and deliver better patient outcomes. Which potential combinations are experts identifying now as being of interest? Will demand accelerate widespread use or will the market hold back for further clinical studies of the most promising combinations?
A report based on expert knowledge
Key Opinion Leaders Interviewed for This Report
North American KOLs
Dr. Naim Alkhouri, MD; Staff Physician, Digestive Disease Institute and Cleveland Clinic’s Children Hospital
Dr. Kenneth Cusi, MD; Chief of the Adult Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Florida
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
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 in Missouri
Prof Philip Rosenthal, MD; Director of Pediatric Hepatology, University of California, San Francisco (UCSF)
Dr. Robert Wong, MD, MS; Assistant Clinical Professor at UCSF, Gastroenterology and Hepatology Faculty
Prof Guruprasad P. Aithal, BSc, MBBS, MD, FRCP, PhD; Head of the division of Nottingham Digestive Diseases Centre, University of Nottingham, UK
Dr. Stefano Bellentani, MD, PhD; Gastroenterologist at Azienda USL di Modena, Italy
Dr. Pinelopi Manousou, MD, PhD; Consultant Hepatologist at St Mary's Hospital, Imperial College 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, UK
Prof Vlad Ratziu, MD, PhD; Professor of Hepatology, Université Pierre et Marie Curie and the Hôpital Pitié-Salpêtrière Medical School, Paris, France
One Anonymous German KOL
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Table of Contents
1 Executive Summary
2 Research Objectives
3 Research Focus
4 Current Treatments
4.2 Vitamin E
4.3 Actos (pioglitazone; Takeda)
5 Pipeline Drugs
5.2 Obeticholic acid (OCA/Ocaliva; Intercept/Sumitomo Dainippon Pharma)
5.3 Elafibranor (GFT505; Genfit)
5.4 Aramchol (Galmed Pharmaceuticals)
5.5 Emricasan (IDN-6556; Conatus Pharmaceuticals)
5.6 Simtuzumab (GS-6624; Gilead)
5.7 Cenicriviroc (TBR-652; Tobira Therapeutics)
5.8 Victoza/Saxenda (liraglutide; Novo Nordisk)
5.9 GS-4997 (Gilead Sciences)
5.10 BMS-986036 (Bristol-Myers Squibb)
6 Future developments in NASH
6.1 Combination approaches will play an important role in the future treatment of NASH
6.2 Diagnosis of NASH using reliable, non-invasive biomarkers remains a critical unmet need
6.3 Key endpoints in NASH clinical trials, novel agents must at least demonstrate
no worsening of fibrosis
6.4 Monitoring long-term responses to treatment, a shift from biopsies to screening
is highly desired in future trials
6.5 Adequacy of NAFLD activity score and HVPG as surrogate endpoints
6.6 Long-term safety and cost-effectiveness will remain challenges for novel therapies
7 Current and future treatment algorithm
9.1 KOL biographies
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