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간질환 관련 유망 기업(2016년) : NASH(비알코올성 지방간염)의 현황을 변화시킬 가능성이 있는 치료 및 진단 옵션의 새로운 출현

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

리서치사 MP Advisors
발행일 2016년 02월 상품 코드 355093
페이지 정보 영문 56 Pages
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간질환 관련 유망 기업(2016년) : NASH(비알코올성 지방간염)의 현황을 변화시킬 가능성이 있는 치료 및 진단 옵션의 새로운 출현 Rising Stars Outlook 2016: New Emergence of Potential Tx & Dx Options could transform the Current Landscape for Liver Diseases (NASH)
발행일 : 2016년 02월 페이지 정보 : 영문 56 Pages

NASH(비알코올성 지방간염) 치료·진단 시장에 대해 조사했으며, 주요 각사의 제품, 임상시험 동향 및 경쟁 구도 등에 대해 분석하여 전해드립니다.

제1장 Conatus Pharmaceuticals(CNAT)

  • Emricasan : 간질환 영역 전체에 걸친 증상완화(Disease Modifying)의 가능성
  • 전체적인 환자의 동향은 MELD 스코어 15 이상 서브그룹에서의 대폭 개선에 의해 촉진된다.
  • Emricasan : PHII(제2상) 데이터, 간경변 임상시험
  • PHIIB, 각 병인·병기의 앙코르 프로그램
  • NASH의 경쟁 구도(후기 개발 단계 파이프라인)
  • Emricasan : 의료 요구·시장 기회
  • Emricasan : 아포토시스·염증성 카스파제의 잠재적 저해요인
  • Emricasan : PHII, 간경변 임상시험(3개월)
  • Emricasan : PHII 데이터@ EASL
  • Emricasan : PHII 데이터@ AASLD
  • 임상, 생화학 및 바이오마커 파라미터의 베이스라인으로부터의 변화

제2장 Galectin Therapeutics(GALT)

  • 후기 단계 NASH의 역전
  • NASH의 경쟁 구도(후기 단계 파이프라인)
  • NASH·섬유 성장의 병태생리학에서 갈렉틴 3의 역할
  • 제2상 임상시험 설계 : NASH-CX(W/ 간경변) & NASH-FX(W/ 진행된 간섬유증)
  • 파이프라인 포트폴리오

제3장 Galmed Pharmaceuticals(GLMD) -Aramcho : 초기 NASH·잠재적 NAFL Pts를 타깃으로 한 어프로치의 차별화

  • 주요 마일스톤
  • NASH의 경쟁 구도(후기 개발 단계 파이프라인)
  • ARAMCHOL:PHIIA 데이터 : 간지방 축적의 상대적 변화
  • ARAMCHOL:작용기서의 차별화
  • ARAMCHOL:임상시험과 엔드포인트
  • PHIIA 결과 : 콜레스테롤·혈청 아디포넥틴의 변화
  • ARAMCHOL 추가 후 콜레스테롤 결정화 레벨의 변화

제4장 Genfit SA(GNFT)

  • GNFT는 우수한 NASH 치료 패키지를 제공 : 안정된 의약품+비침습 바이오마커 검사
  • GOLDEN-505: 기타 PHII 연구와의 비교
  • NASH의 경쟁 구도(후기 단계 파이프라인)
  • ELAFIBRANOR : PHIII 임상시험 설계
  • GOLDEN-505:심장 - 대사 및 혈중 파라미터의 개선 등

제5장 Intercept Pharmaceuticals(ICPT)

  • 세계의 PBC 환자 워터폴
  • FLINT 시험 결과 : NAS, 간섬유증 및 NASH 해상도의 개선
  • 경쟁 구도
  • POISE 시험
  • NASH용으로 개발중인 약제 등
KSA 16.04.06

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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