한글목차

Finch Therapeutics가 개발중인 CP101은 마이크로바이옴 기능 장애와 관련된 질환을 대상으로 임상시험중인 경구용 마이크로바이옴 치료제로, CP101은 경구용 장용성 캡슐로 완전한 마이크로바이옴 커뮤니티를 제공합니다. 이 약물은 rCDI 예방을 목적으로 후기 임상 개발 단계에 있습니다. 회사는 CP101을 만성 B형 간염 치료제로 평가하는 것을 시작으로 마이크로바이옴 붕괴와 관련된 다른 질병에 대한 개발을 계획하고 있습니다.

최근 미국 FDA는 Finch Therapeutics의 CP101 임상시험계획(IND) 신청에 대한 임상 보류를 해제했습니다. 회사는 rCDI 예방을 위한 CP101의 PRISM4(임상 3상) 시험을 진행하고 있으며, PRISM4의 탑라인 데이터는 2024년 상반기에 나올 것으로 예상하고 있습니다.

앞으로 수년간 클로스트리듐 디피실 감염증 시장 시나리오는 세계에서 광범위한 조사와 의료비 지출 증가로 인해 변화할 것으로 예상됩니다. 각 업체들은 질환을 치료/개선하기 위한 새로운 접근 방식에 초점을 맞춘 치료법을 개발하고, 과제를 평가하고, CP101의 우위에 영향을 미칠 수 있는 기회를 모색하고 있습니다. 클로스트리듐 디피실 감염에 대한 다른 신흥 제품들은 CP101과 치열한 시장 경쟁을 벌일 것으로 예상되며, 가까운 시일 내에 후발주자 신약이 출시되면 시장에 큰 영향을 미칠 것으로 보입니다.

주요 7개국의 CP101 시장에 대해 조사했으며, 시장의 개요와 2025-2032년 판매 예측 데이터, 경쟁 구도 및 국가별 동향 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 클로스트리듐 디피실 감염증에 대한 CP101의 개요

• 제품 상세
• 임상 개발
  • 임상 연구
  • 임상시험 정보
  • 안전성과 유효성
• 기타 개발 활동
• 제품 개요

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 단계 신규 치료법)

제5장 CP101 시장 평가

• 클로스트리듐 디피실 감염증에 대한 CP101의 시장 전망
• 주요 7개국 시장 분석
  • 주요 7개국의 클로스트리듐 디피실 감염증에 대한 CP101의 시장 규모
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

“"CP101 Emerging Drug Insight and Market Forecast - 2032" report provides comprehensive insights about CP101 for clostridium difficile infection (CDI) in the seven major markets. A detailed picture of the CP101 for clostridium difficile infection in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the CP101 for clostridium difficile infection. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the CP101 market forecast analysis for clostridium difficile infection in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in clostridium difficile infection.

Drug Summary:

CP101, being developed by Finch Therapeutics, is an investigational, orally administered microbiome drug for conditions linked to microbiome dysfunction. CP101 delivers complete microbiome communities in orally administered, enteric-release capsules. The drug is in late-stage clinical development for the prevention of rCDI. The company is planning to deploy CP101 to other conditions linked to microbiome disruption, starting with the evaluation of CP101 as a treatment for chronic hepatitis B.

Recently, the US FDA removed the clinical hold on Finch's Investigational New Drug (IND) application for CP101. The company has proceeded with patient dosing in the PRISM4 (Phase III) trial of CP101 for the prevention of rCDI, and anticipates topline data from PRISM4 in H1 2024.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the CP101 description, mechanism of action, dosage and administration, research and development activities in clostridium difficile infection.
• Elaborated details on CP101 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the CP101 research and development activities in clostridium difficile infection across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around CP101.
• The report contains forecasted sales of CP101 for clostridium difficile infection till 2032.
• Comprehensive coverage of the late-stage emerging therapies for clostridium difficile infection.
• The report also features the SWOT analysis with analyst views for CP101 in clostridium difficile infection.

Methodology:

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

CP101 Analytical Perspective by DelveInsight

In-depth CP101 Market Assessment

This report provides a detailed market assessment of CP101 for clostridium difficile infection in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2025 to 2032.

CP101 Clinical Assessment

The report provides the clinical trials information of CP101 for clostridium difficile infection covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for clostridium difficile infection is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence CP101 dominance.
• Other emerging products for clostridium difficile infection are expected to give tough market competition to CP101 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of CP101 in clostridium difficile infection.
• Our in-depth analysis of the forecasted sales data of CP101 from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the CP101 in clostridium difficile infection.

Key Questions:

• What is the product type, route of administration and mechanism of action of CP101?
• What is the clinical trial status of the study related to CP101 in clostridium difficile infection and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the CP101 development?
• What are the key designations that have been granted to CP101 for clostridium difficile infection?
• What is the forecasted market scenario of CP101 for clostridium difficile infection?
• What are the forecasted sales of CP101 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to CP101 for clostridium difficile infection?
• Which are the late-stage emerging therapies under development for the treatment of clostridium difficile infection?

Table of Contents

1. Report Introduction

2. CP101 Overview in Clostridium difficile infection

• 2.1. Product Detail
• 2.2. Clinical Development
  • 2.2.1. Clinical studies
  • 2.2.2. Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. CP101 Market Assessment

• 5.1. Market Outlook of CP101 in Clostridium difficile infection
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of CP101 in the 7MM for Clostridium difficile infection
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of CP101 in the United States for Clostridium difficile infection
  • 5.3.2. Market Size of CP101 in Germany for Clostridium difficile infection
  • 5.3.3. Market Size of CP101 in France for Clostridium difficile infection
  • 5.3.4. Market Size of CP101 in Italy for Clostridium difficile infection
  • 5.3.5. Market Size of CP101 in Spain for Clostridium difficile infection
  • 5.3.6. Market Size of CP101 in the United Kingdom for Clostridium difficile infection
  • 5.3.7. Market Size of CP101 in Japan for Clostridium difficile infection

6. SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options