New Report Study 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!
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.
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Key Points from Table of Content
- 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
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
- 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
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Posted by
Rajat Sahni
on Wednesday March 30 2016, 6:43 PM EST.
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