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市場調查報告書

肝臟疾病潛力企業 2016年:可能改變NASH (非酒精性脂肪變性肝炎) 現狀的新治療、診斷選項

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

出版商 MP Advisors 商品編碼 355093
出版日期 內容資訊 英文 56 Pages
商品交期: 最快1-2個工作天內
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肝臟疾病潛力企業 2016年:可能改變NASH (非酒精性脂肪變性肝炎) 現狀的新治療、診斷選項 Rising Stars Outlook 2016: New Emergence of Potential Tx & Dx Options could transform the Current Landscape for Liver Diseases (NASH)
出版日期: 2016年02月01日 內容資訊: 英文 56 Pages
簡介

本報告針對NASH (非酒精性脂肪變性肝炎) 治療、診斷市場進行調查、提供主要公司的主要產品、治療動向、競爭情況分析。

第1章 Conatus Pharmaceuticals (CNAT)

  • Emricasan:肝臟疾病整體緩和疾病藥物潛力
  • 整體患者動向因MELD□15以上群體有大幅改善
  • Emricasan:PHII(第2期) 資料、肝硬化治療
  • PHIIB、各病因、病期Encore計畫
  • NASH競爭情況 (後期開發階段臨床)
  • Emricasan:醫療需求、市場機會
  • Emricasan:細胞凋亡、炎性Caspase潛在阻礙因素
  • Emricasan:PHII、肝硬化治療 (3個月)
  • Emricasan:PHII資料@ EASL
  • Emricasan:PHII資料@ AASLD
  • 臨床、生化學、生物標誌參數基準變化

第2章 Galectin Therapeutics (GALT)

  • 後期階段NASH逆轉
  • NASH競爭情況 (後期階段臨床)
  • NASH、纖維化成長病況生理學中GALECTIN-3的角色
  • 第2期治療設計:NASH-CX (W/ 肝硬化) & NASH-FX (W/ 進行肝纖維化)
  • 臨床資料

第3章 Galmed Pharmaceuticals (GLMD)-Aramcho:以初期NASH、潛在NAFL Pts為目標的過程差別

  • 主要基石
  • NASH競爭情況 (後期開發階段臨床)
  • ARAMCHOL:PHIIA 資料:肝脂肪累積相對變化
  • ARAMCHOL:作用機序差別
  • ARAMCHOL:治療與終點
  • PHIIA結果:膽固醇、血清脂聯素變化
  • ARAMCHOL追加後的膽固醇結晶程度變化

第4章 Genfit SA (GNFT)

  • GNFT提供更溫和的NASH治療組:安定的醫藥品+非侵入式生物標記檢查
  • GOLDEN-505: 其他PHII研究與比較
  • NASH競爭情況 (後期階段臨床)
  • ELAFIBRANOR:PHIII治療設計
  • GOLDEN-505:心臟 - 代謝與血液中參數改善、其他

第5章 Intercept Pharmaceuticals (ICPT)

  • 世界PBC患者
  • FLINT測試結果:NAS、肝纖維症、NASH解析度改善
  • 競爭情況
  • POISE測試
  • NASH開發中的藥劑、其他
目錄
Product Code: 4487

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.

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

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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