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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