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肝臓病の有望企業 2016年:NASH (非アルコール性脂肪性肝炎) の現状を変える可能性のある治療・診断オプションの新たな出現

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

発行 MP Advisors 商品コード 355093
出版日 ページ情報 英文 56 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=107.13円で換算しております。
肝臓病の有望企業 2016年:NASH (非アルコール性脂肪性肝炎) の現状を変える可能性のある治療・診断オプションの新たな出現 Rising Stars Outlook 2016: New Emergence of Potential Tx & Dx Options could transform the Current Landscape for Liver Diseases (NASH)
出版日: 2016年02月01日 ページ情報: 英文 56 Pages
概要

当レポートでは、NASH (非アルコール性脂肪性肝炎) 治療・診断市場について調査し、主要各社の主要製品、治験動向、および競合情勢などについて分析しています。

第1章 Conatus Pharmaceuticals (CNAT)

  • Emricasan:肝臓病の領域全体にわたる予防維持薬の可能性
  • 全体的な患者の動向はMELDスコア15以上のサブグループにおける大幅な改善によって促進される
  • Emricasan:PHII(第2相) データ、肝硬変治験
  • PHIIB、各病因・病期におけるアンコールプログラム
  • NASHの競合情勢 (後期開発段階パイプライン)
  • Emricasan:医療ニーズ・市場機会
  • Emricasan:アポトーシス・炎症性カスパーゼの潜在的阻害因子
  • Emricasan:PHII、肝硬変治験 (3ヵ月)
  • Emricasan:PHIIデータ@ EASL
  • Emricasan:PHIIデータ@ AASLD
  • 臨床、生化学、およびバイオマーカーパラメーターにおけるベースラインからの変化

第2章 Galectin Therapeutics (GALT)

  • 後期段階NASHの逆転
  • NASHの競合情勢 (後期段階パイプライン)
  • NASH・線維成長の病態生理学におけるガレクチン3の役割
  • 第2相治験設計:NASH-CX (W/ 肝硬変) & NASH-FX (W/ 進行した肝線維症)
  • パイプラインのポートフォリオ

第3章 Galmed Pharmaceuticals (GLMD)-Aramcho:初期のNASH・潜在的NAFL Ptsをターゲットにした、アプローチの差別化

  • 主なマイルストーン
  • NASHの競合状況 (後期開発段階パイプライン)
  • ARAMCHOL:PHIIA データ:肝脂肪蓄積における相対的変化
  • ARAMCHOL:作用機序の差別化
  • ARAMCHOL:治験とそのエンドポイント
  • PHIIAの結果:コレステロール・血清アディポネクチンの変化
  • ARAMCHOL追加後のコレステロール結晶化のレベルの変化

第4章 Genfit SA (GNFT)

  • GNFTは優れたNASH治療パッケージを提供:安定した医薬品+非侵襲バイオマーカー検査
  • GOLDEN-505: その他のPHII研究との比較
  • NASHの競合情勢 (後期段階パイプライン)
  • ELAFIBRANOR:PHIII治験設計
  • GOLDEN-505:心臓 - 代謝および血中パラメーターの改善、ほか

第5章 Intercept Pharmaceuticals (ICPT)

  • 世界におけるPBC患者のウォーターフォール
  • FLINT試験結果:NAS、肝線維症、およびNASH解像度の改善
  • 競合情勢
  • POISE試験
  • NASH向けに開発中の薬剤、ほか
目次
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