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Rising Stars Outlook 2016 :New Emergence of Potential Tx & Dx Options could transform the Current Landscape for Liver Diseases

Rising Stars Outlook 2016 :New Emergence of Potential Tx & Dx Options could transform the Current Landscape for Liver Diseases (NASH)
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Published by MP Advisors: 01 Feb 2016 | 20126 | In Stock
Related Topics: FDA , Hepatitis

Introduction

Non-Alcoholic SteatoHepatitis (NASH) is an unmet medical need and is becoming the leading cause of liver transplant. No FDA-approved therapies and a meager diagnosis, it poses a unique challenge in the design of studies for NASH. Therefore, there is a worldwide need for new therapies to treat the global epidemic of NASH and the cost to society will be huge if it is not addressed in the upcoming years! Besides, scarcity of treatment options, there is also an urgent unmet need to develop biomarkers that facilitate the diagnosis, identification of populations at risk, assessment of disease progression or regression, and/or response to treatment. The potential market is gigantic with analysts predicting north of bn by 2025!

Many small players are currently developing drugs on their own and with such a large unmet need, market potential and disease heterogeneity, we expect many Giants to join this race and thus, we can see more Licensing deals/ M&A activity on the horizon! In light of recent developments in NASH, we have added few in-depth coverage of companies which either target early-stage NASH, late-stage NASH, or large pts pool-NAFLD in our Outlook this year

Table of Contents
for Rising Stars Outlook 2016 :New Emergence of Potential Tx & Dx Options could transform the Current Landscape for Liver Diseases (NASH)

  • 1. Conatus Pharmaceuticals (CNAT)

    -

    Emricasan: Disease Modifying Potential across the Spectrum of Liver Diseases

    - KEY MILESTONES (CNAT)

    - 2. Trends in overall population driven by significant improvement in MELD ?15 subgroup

    Figure 1

    Conatus Pharma

    EMRICASAN: DATA FROM PHII, LIVER CIRRHOSIS TRIAL (3-MONTH

    - Table 1

    Conatus Pharma

    PHIIB, ENCORE PROGRAM IN DIFFERENT ETIOLOGIES & STAGES

    - Table 2

    Conatus Pharma

    COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH

    - Figure 2

    Conatus Pharma

    EMRICASAN: MEDICAL NEED AND MARKET OPPORTUNITIES

    - Figure 3

    Conatus Pharma

    EMRICASAN: A POTENT INHIBITOR OF APOPTOTIC AND INFLAMMATORY CASPASES

    - Figure 4

    Conatus Pharma

    EMRICASAN: PHASE II, LIVER CIRRHOSIS TRIAL (3 MONTHS)

    - Figure 5

    Conatus Pharma

    EMRICASAN: PHASE II DATA @ EASL, 2015

    - Figure 6

    Conatus Pharma

    EMRICASAN: PHASE II DATA @ AASLD, 2015

    - Changes in Clinical, Biochemical, and Biomarker parameter from Baseline

    -

    2. Galectin Therapeutics (GALT)

    - Reversing Late-Stage NASH (Advanced Fibrosis)

    -KEY MILESTONES (GALT)

    - COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH

    -ROLE OF GALECTIN-3 IN PATHOPHYSIOLOGY OF NASH AND FIBROGENESIS

    - PHASE II TRIAL DESIGNS: NASH-CX (W/ CIRRHOSIS) & NASH-FX (W/ ADVANCED FIBROSIS)

    - GR-MD-02: PHI STUDY – SERUM BIOMARKERS EVALUATION

    - Figure 4

    Galectin Therapeutics

    GR-MD-02: PRECLINICAL DATA – TX EFFECT ON NASH WITH FIBROSIS

    - Figure

    Galectin Therapeutics

    PIPELINE PORTFOLIO

    -

    3. Galmed Pharmaceuticals (GLMD)-Aramchol: A Differentiated Approach, Targeting Early NASH and Potentially, NAFL Pts

    - KEY MILESTONES (GLMD)

    - Table 1

    Galmed Pharmaceuticals

    COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH

    - Figure 1

    Galmed Pharmaceuticals

    ARAMCHOL: PHASE IIA DATA – RELATIVE CHANGE IN LIVER-FAT CONCENTRATION

    - Figure 2

    Galmed Pharmaceuticals

    ARAMCHOL: DIFFERENTIATED MODE OF ACTION

    - Figure 3

    Galmed Pharmaceuticals

    ARAMCHOL: CLINICAL TRIALS AND ITS ENDPOINTS

    - Figure 4

    Galmed Pharmaceuticals

    PHIIA RESULTS: CHANGES IN CHOLESTEROL AND SERUM ADIPONECTIN LEVELS

    - Figure 5

    Galmed Pharmaceuticals

    CHANGES IN THE LEVELS OF CHOLESTEROL CRYSTALLIZATION AFTER THE ADDITION OF ARAMCHOL

    4. Genfit SA (GNFT)

    - GNFT offers Remarkable NASH Treatment Package: Robust Drug + Non-Invasive Biomarker Test

    - KEY MILESTONES (GNFT)

    - Figure 1

    Genfit SA

    GOLDEN-505: COMPARISON WITH OTHER PHII STUDIES

    - Figure 2

    Genfit SA

    GOLDEN-505: COMPARISON WITH OTHER PHII STUDIES

    - Table 1

    Genfit SA

    COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH

    - Table 1

    Genfit SA – Continued…

    COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH

    - Figure 3

    Genfit SA

    ELAFIBRANOR: PPAR REGULATES NUMEROUS PATHWAYS ESSENTIAL IN NASH

    - CLINICAL DEVELOPMENT

    -Figure 4

    Genfit SA

    ELAFIBRANOR: PHASE III TRIAL DESIGN

    - Figure 5A

    Genfit SA

    GOLDEN-505: IMPROVEMENT IN CARDIO-METABOLIC AND GLYCEMIC PARAMETERS

    - Figure 6

    Genfit SA

    EFFICACY OF GFT505 IN ANIMAL MODELS OF NAFLD/ NASH AND LIVER FIBROSIS

    - Figure 7

    Genfit SA

    EFFICACY OF GFT505 IN ANIMAL MODELS OF NAFLD/ NASH AND LIVER FIBROSIS

    - Figure 8

    Genfit SA

    EFFECTS OF GFT505 IN RATS WITH ESTABLISHED HEPATIC FIBROSIS

    - Figure 8

    Genfit SA – Continued…

    EFFECTS OF GFT505 IN RATS WITH ESTABLISHED HEPATIC FIBROSIS

    -

    5. Intercept Pharmaceuticals (ICPT)

    - Mixed Data and Pricing/Reimbursement Concerns may Limit OCA’s Market Potential

    - Figure 1

    Intercept Pharmaceuticals

    GLOBAL PBC PATIENT WATERFALL

    - KEY MILESTONES (ICPT)

    - Figure 2

    Intercept Pharmaceuticals

    FLINT STUDY RESULTS: IMPROVEMENT IN NAS, FIBROSIS, AND NASH RESOLUTION

    - Table 1

    Intercept Pharmaceuticals

    COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH

    - Figure 3

    Intercept Pharmaceuticals

    FXR IS CENTRAL TO A MULTITUDE OF PATHWAYS

    - Figure 5

    Intercept Pharmaceuticals

    POISE STUDY: MET THE PRIMARY ENDPOINT AS EARLY AS 2 WEEKS

    - Figure 6

    6. Intercept Pharmaceuticals

    FLINT STUDY: RESPONSE RATES, FIBROSIS IMPROVEMEN

    - KEY MILESTONES

    -

    --- Figure 1

    Tobira Therapeutics

    CENTAUR - PHIIB CLINICAL TRIAL VS. OTHER PUBLISHED PHIIB STUDIES IN NASH

    (TBRA)

    Tobira Therapeutics

    CENICRIVIROC (CVC): A POTENT INHIBITOR OF INFILTRATION OF PRO-INFLAMMATORY MONOCYTES

    obira Therapeutics

    DRUGS IN DEVELOPMENT FOR NASH

Additional Details

Publisher

MP Advisors

Publisher Information

Reference

20126 | 4487

Number of Pages

56

Report Format

PDF

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