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25+ Leading Primary Biliary Cirrhosis Pipeline Companies are working to improve the Treatment Landscape

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25+ Leading Primary Biliary Cirrhosis Pipeline Companies are working to improve the Treatment Landscape

February 27
10:05 2023
25+ Leading Primary Biliary Cirrhosis Pipeline Companies are working to improve the Treatment Landscape

DelveInsight’s, “Primary biliary cirrhosis Pipeline Insight, 2023” report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in Primary biliary cirrhosis pipeline landscape. It covers the Primary Biliary Cirrhosis pipeline drug profiles, including Primary Biliary Cirrhosis clinical trials and nonclinical stage products. It also covers the Primary Biliary Cirrhosis pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. 

 

In the Primary Biliary Cirrhosis Pipeline Report, detailed description of the drug is given which includes mechanism of action of the drug, Primary Biliary Cirrhosis clinical trials studies, Primary Biliary Cirrhosis NDA approvals (if any), and product development activities comprising the technology, Primary biliary cirrhosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Key takeaways from the Primary Biliary Cirrhosis Pipeline Report

 

  • DelveInsight’s primary biliary cirrhosis pipeline report depicts a robust space with 25+ active players working to develop 25+ pipeline therapies for primary biliary cirrhosis treatment.

 

  • The leading primary biliary cirrhosis companies such as Genfit, CymaBay Therapeutics, Calliditas Therapeutics, Zydus-Cadila, Cour Pharmaceutical, Mirum Pharmaceuticals, HighTide Biopharma, PRISM Pharma Co, Albireo Pharma, Pliant Therapeutics, GentiBio, Gannex Pharma, Selecta Biosciences, Intercept Pharmaceuticals, Umecrine Cognition, Suzhou Zelgen Biopharmaceuticals, Merck Sharp & Dohme LLC, Kowa Pharmaceuticals, and others.

 

  • Promising primary biliary cirrhosis pipeline therapies such as Elafibranor, Seladelpar, Setanaxib, Bilypsa, CNP-104, ASC42, Volixibat, Bezafibrate, HTD1801, OP-724, A3907, PDC-E2, HM15211, Pemafibrate, Emtricitabine/Tenofovir Disoproxil/Raltegravir, Research program, Pemafibrate, and others

 

  • The Primary Biliary Cirrhosis companies and academics are working to assess challenges and seek opportunities that could influence Primary biliary cirrhosis R&D. The Primary Biliary Cirrhosis pipeline therapies under development are focused on novel approaches to treat/improve Primary biliary cirrhosis.

 

Request a sample and discover the recent breakthroughs happening in the Primary Biliary Cirrhosis pipeline landscape @ Primary Biliary Cirrhosis Pipeline Outlook Report

 

Primary Biliary Cirrhosis Overview

Primary biliary cirrhosis (PBC) is a chronic and slowly progressive cholestatic liver disease of autoimmune etiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. Affected individuals are usually in their fifth to seventh decades of life at time of diagnosis, and 90% are women. Annual incidence is estimated between 0.7 and 49 cases per million-population and prevalence between 6.7 and 940 cases per million-population (depending on age and sex). PBC does not always cause symptoms, but some people may experience: bone and joint aches, fatigue (extreme tiredness), itchy skin, dry eyes and mouth, pain or discomfort in the upper right side of their tummy.

 

Latest Developmental Activities in the Primary Biliary Cirrhosis Treatment Landscape

 

 

  • In November 2022, CymaBay Therapeutics, Inc. announced encouraging seladelpar data in patients with primary biliary cholangitis (PBC) that were presented at The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, DC (November 4th – 8th). A clinical poster presentation titled “Seladelpar Improved the Lipid Profile of Patients with Primary Biliary Cholangitis (PBC): Results from Phase 2 and 3 Clinical Studies” reported positive results and showed that treatment with seladelpar resulted in significant improvements in total cholesterol (TC), LDL-C, HDL-C, and triglycerides (TG). A second poster presenting clinical data titled “Seladelpar, a PPAR-delta Agonist, Improves Inflammatory Lipid Mediators in the Serum Metabolome in Patients with Primary Biliary Cholangitis (PBC)” revealed that seladelpar treatment in patients with PBC resulted in broad changes in serum metabolomics.

 

  • In August 2022, Gannex Pharma Co., Ltd., owned by Ascletis Pharma Inc., announced that it had finished its first dosing in the US drug-drug interaction (DDI) study of Farnesoid X Receptor agonist ASC42 for treatment of PBC. The DDI study and ongoing phase II clinical trial in PBC patients in China will provide more evidence to support upcoming phase III trials in the US, China, and the European Union.

 

  • GENFIT is currently evaluating its proprietary drug candidate, elafibranor, a dual agonist of PPARα and PPARδ in PBC. Enrollment is ongoing for the Phase III clinical trial ELATIVE (NCT04526665), which aims to confirm elafibranor 80mg efficacy, based upon changes in biochemical parameters and its potential to improve pruritus, and safety in patients with PBC. Elafibranor was granted Breakthrough Therapy designation by the FDA in April 2019 for the treatment of PBC in adults with inadequate response to UDCA, as well as Orphan Drug Designation by the FDA and the EMA (European Medicines Agency) in July 2019. In November 2022, Genfir announced that Phase III data for elafibranor in primary biliary cholangitis (PBC) is  expected in 2Q23.

 

  • CNP-104 is being developed utilizing Cour’s nanoparticle platform (CNP), a novel, proprietary system which combines disease-specific pathogenic antigens with state-of-the-art pharmaceutical nanoparticles that mimic normal removal of dead or dying cells from the body. Cour’s platform has shown proof of technology in clinical and preclinical settings. COUR is currently conducting a clinical study with top-line data expected to read out in 2023. In January 2022, the US Food and Drug Administration (FDA) granted Fast Track designation to CNP-104 for the treatment of primary biliary cholangitis (PBC).

 

Find out more about the Primary Biliary Cirrhosis Diagnosis and Treatment of patients @ Primary Biliary Cirrhosis Ongoing Clinical Trials Analysis

 

Primary Biliary Cirrhosis Emerging Drugs Profile

 

Elafibranor:  Genfit

Elafibranor is an investigational compound. GENFIT is currently evaluating its proprietary drug candidate, elafibranor, a dual agonist of PPARα and PPARδ in PBC. Targeting PPAR receptors may result in a reduction of bile acid synthesis, improved detoxification of bile in the bile duct and anti-inflammatory activity. The use of drugs targeting PPAR receptors has been shown to reduce blood levels of Alkaline Phosphatase (ALP), and improve biochemical measures of cholestasis and pruritus (itching) in patients with PBC.

 

Seladelpar:  CymaBay Therapeutics

Seladelpar (MBX-8025) is a potent, selective, orally active peroxisome proliferator-activated receptor δ (PPARδ) agonist in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC). It has received Breakthrough Therapy Designation (FDA) and PRIME status (EMEA); Orphan Drug Designation in U.S. and Europe. Backed by an extensive body of clinical evidence and global patient experience through its Phase 2 and Phase 3 (ENHANCE) studies of seladelpar in Primary Biliary Cholangitis (PBC), CymaBay initiated an international pivotal Phase 3 study (RESPONSE) in early 2021.

 

Setanaxib: Calliditas Therapeutics

Calliditas’ pipeline contains development programs based on a first in class, novel NOX inhibitor platform that includes lead compound setanaxib, the first NOX inhibitor to reach the clinical trial stage. NOX enzyme inhibitors are a set of promising novel experimental drugs in a new therapeutic class, recognised by the WHO since 2019 when it approved “naxib” as a new stem. Calliditas launched trials with setanaxib in Primary Biliary Cholangitis (PBC) and in Squamous Cell Carcinoma of the Head & Neck (SCCHN).

 

Primary Biliary Cirrhosis Pipeline Therapeutics Assessment

There are approx. 25+ key companies which are developing the therapies for Primary biliary cirrhosis. The companies which have their Primary biliary cirrhosis drug candidates in the most advanced stage, i.e. phase III include, Genfit.

 

Discover more about the list of Primary Biliary Cirrhosis FDA-approved drugs for Primary Biliary Cirrhosis @ Primary Biliary Cirrhosis Treatment Landscape

 

Scope of the Primary Biliary Cirrhosis Pipeline Report

 

  • Coverage- Global

 

  • Primary Biliary Cirrhosis Companies- Genfit, CymaBay Therapeutics, Calliditas Therapeutics, Zydus-Cadila, Cour Pharmaceutical, Mirum Pharmaceuticals, HighTide Biopharma, PRISM Pharma Co, Albireo Pharma, Pliant Therapeutics, GentiBio, Gannex Pharma, Selecta Biosciences, Intercept Pharmaceuticals, Umecrine Cognition, Suzhou Zelgen Biopharmaceuticals, Merck Sharp & Dohme LLC, Kowa Pharmaceuticals, and others.

 

  • Primary Biliary Cirrhosis Pipeline Therapies- Elafibranor, Seladelpar, Setanaxib, Bilypsa, CNP-104, ASC42, Volixibat, Bezafibrate, HTD1801, OP-724, A3907, PDC-E2, HM15211, Pemafibrate, Emtricitabine/Tenofovir Disoproxil/Raltegravir, Research program, Pemafibrate, and others

 

  • Primary Biliary Cirrhosis Pipeline Segmentation: Product Type, Molecule Type, Route of Administration, Mechanism of Action 

 

Dive deep into rich insights for Primary Biliary Cirrhosis Emerging Therapies and Ongoing Clinical Trials; visit @ Primary Biliary Cirrhosis Emerging Therapies and Key Players

 

 

Table of Content

  1. Introduction
  2. Executive Summary
  3. Primary biliary cirrhosis: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Primary biliary cirrhosis– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Elafibranor:  Genfit
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Drug name : Company name
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. Drug name : Company name
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. Drug name : Company name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Primary biliary cirrhosis Key Companies
  21. Primary biliary cirrhosis Key Products
  22. Primary biliary cirrhosis- Unmet Needs
  23. Primary biliary cirrhosis- Market Drivers and Barriers
  24. Primary biliary cirrhosis- Future Perspectives and Conclusion
  25. Primary biliary cirrhosis Analyst Views
  26. Primary biliary cirrhosis Key Companies
  27. Appendix

 

For further information on the Primary Biliary Cirrhosis Pipeline therapeutics, reach out to Primary Biliary Cirrhosis Market Drivers and Barriers

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