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

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Date: 01-Jan-2016
No. of pages: 56
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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 $35bn 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.

Companies Mentioned


  • Conatus Pharmaceuticals (CNAT)

  • Galectin Therapeutics (GALT)

  • Galmed Pharmaceuticals (GLMD)

  • Genfit SA (GNFT)

  • Intercept Pharmaceuticals (ICPT)

  • Tobira Therapeutics (TBRA)


 

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

Table of Contents

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
FLINT STUDY: RESPONSE RATES, FIBROSIS IMPROVEMEN
- KEY MILESTONES

6 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
Tobira Therapeutics
DRUGS IN DEVELOPMENT FOR NASH

List of Tables

KEY MILESTONES (CNAT)
Gelectin Therapeutics : Key Milestone Table
Table1
Conatus Pharma
PHIIB, ENCORE PROGRAM IN DIFFERENT ETIOLOGIES & STAGES
Table 2
Conatus Pharma
COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH
Table 1
Galectin Therapeutics
COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH
Galmed - Key Milestone Table
Table 1
Galmed Pharmaceuticals
COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH
Table 1
Genfit SA
COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH
Intercept : Key Milestone Table
Table 1
Intercept Pharmaceuticals
COMPETITIVE LANDSCAPE (LATE-STAGE PIPELINE) FOR NASH
Table 1
Tobira Therapeutics
DRUGS IN DEVELOPMENT FOR NASH
Table 2
Tobira Therapeutics
CENICRIVIROC (CVC): PHIIB DATA IN HIV PTS - FAVORABLE 48-WEEK SAFETY (COMBINED WITH FTC/TDF)

List of Figures

Figure 1
Conatus Pharma
EMRICASAN: DATA FROM PHII, LIVER CIRRHOSIS TRIAL (3-MONTHS)
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
Figure 1
Galectin Therapeutics
ROLE OF GALECTIN-3 IN PATHOPHYSIOLOGY OF NASH AND FIBROGENESIS
Figure 2
Galectin Therapeutics
PHASE II TRIAL DESIGNS: NASH-CX (W/ CIRRHOSIS) & NASH-FX (W/ ADVANCED FIBROSIS
Figure 3
Galectin Therapeutics
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
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
Figure 1
Genfit SA
GOLDEN-505: COMPARISON WITH OTHER PHII STUDIES
Figure 2
Genfit SA
GOLDEN-505: COMPARISON WITH OTHER PHII STUDIES
Figure 3
Genfit SA
ELAFIBRANOR: PPAR??? REGULATES NUMEROUS PATHWAYS ESSENTIAL IN NASH
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 1
Intercept Pharmaceuticals
GLOBAL PBC PATIENT WATERFALL
Figure 2
Intercept Pharmaceuticals
FLINT STUDY RESULTS: IMPROVEMENT IN NAS, FIBROSIS, AND NASH RESOLUTION
Figure 3
Intercept Pharmaceuticals
FXR IS CENTRAL TO A MULTITUDE OF PATHWAYS
Figure 4
Intercept Pharmaceuticals
POOLED DATA IN PBC: ABSOLUTE AND PERCENT REDUCTION IN ALP
Figure 5
Intercept Pharmaceuticals
POISE STUDY: MET THE PRIMARY ENDPOINT AS EARLY AS 2 WEEKS
Figure 6
Intercept Pharmaceuticals
FLINT STUDY: RESPONSE RATES, FIBROSIS IMPROVEMENT, AND PROGRESSION IN HIGH-RISK PATIENT GROUPS
Figure 7
Intercept Pharmaceuticals
FLINT STUDY: RESPONSE RATES, FIBROSIS IMPROVEMENT, AND PROGRESSION IN HIGH-RISK PATIENT GROUPS
Figure 8
Intercept Pharmaceuticals
HEALTH ECONOMICS MODELLING FOR PBC AND LIVER DISEASE
Figure 9
Intercept Pharmaceuticals
PIPELINE PORTFOLIO
Figure 1
Tobira Therapeutics
CENTAUR - PHIIB CLINICAL TRIAL VS. OTHER PUBLISHED PHIIB STUDIES IN NASH
Figure 2
Tobira Therapeutics
CENICRIVIROC (CVC): A POTENT INHIBITOR OF INFILTRATION OF PRO-INFLAMMATORY MONOCYTES
Figure 3
Tobira Therapeutics
CENICRIVIROC (CVC): NASH MOUSE MODEL - REDUCTION IN FIBROSIS AND NAFLD ACTIVITY SCORE (NAS)
Figure 4
Tobira Therapeutics
CENICRIVIROC (CVC): LIPID PROFILE - CHANGES FROM BASELINE
Figure 5
Tobira Therapeutics
CENICRIVIROC (CVC): LIPID PROFILE - CHANGES FROM BASELINE
Figure 6
Tobira Therapeutics
CENICRIVIROC (CVC): PRODUCT PIPELINE
Chart 1:
Daiichi Sankyo
Efficacy comparison of Quizartinib vs. ASP-2215
Chart 4
Daiichi Sankyo
New NOAC share vs. Warfarin- Warfarin still holds >60% share in US
New NOAC share vs. Warfarin- Warfarin still holds >60% share in US
iichi Sankyo
US TRX of each NOAC since launch

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