New Emergence of Potential Tx & Dx Options Predicted to Transform the Current Landscape for Liver Diseases (NASH) to a $35 Billion Opportunity

Feb 26, 2016, 05:10 ET from Research and Markets


DUBLIN, Feb. 26, 2016 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/8kq9f9/new_emergence_of) has announced the addition of the "New Emergence of Potential Tx & Dx Options could transform the Current Landscape for Liver Diseases (NASH)" report to their offering.

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

Key Topics Covered:

1. Conatus Pharmaceuticals (CNAT)

- Emricasan: Disease Modifying Potential Across The Spectrum Of Liver Diseases

- Key Milestones (CNAT)

- 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 5 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

- Phase II 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 - Part 2 - 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 - 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

Companies Mentioned

- Conatus Pharmaceuticals (CNAT) - Galectin Therapeutics (GALT) - Galmed Pharmaceuticals (GLMD) - Genfit SA (GNFT) - Intercept Pharmaceuticals (ICPT) - Tobira Therapeutics (TBRA)

For more information visit http://www.researchandmarkets.com/research/8kq9f9/new_emergence_of

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