New Emergence of Potential Tx & Dx Options could transform the Current Landscape for Liver Diseases Market

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Rising Stars Outlook 2016 - New Emergence of Potential Tx &
Dx Options could transform the Current Landscape for Liver
Diseases (NASH)
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!
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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 Content
1. Conatus Pharmaceuticals (CNAT)
Emricasan: Disease Modifying Potential across the Spectrum of Liver Diseases
- KEY MILESTONES (CNAT)
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- 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)
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- 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
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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
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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.

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