New York, USA, Jan. 23, 2023 (GLOBE NEWSWIRE) -- Primary Biliary Cirrhosis Clinical Trial Pipeline Insights Featuring 22+ Companies | DelveInsight
Primary biliary cholangitis, previously called primary biliary cirrhosis, is a chronic disease in which the bile ducts in the liver are slowly destroyed. Rising healthcare expenditure is one such factor that has influenced the growth rate of PBC. An increase in the number of research and development activities has also led Pharmaceutical companies to develop novel therapies for the treatment of PBC.
DelveInsight’s 'Primary Biliary Cirrhosis Pipeline Insight 2023' report provides comprehensive global coverage of available, marketed, and pipeline primary biliary cirrhosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the primary biliary cirrhosis pipeline domain.
Key Takeaways from the Primary Biliary Cirrhosis Pipeline Report
- DelveInsight’s primary biliary cirrhosis pipeline report depicts a robust space with 22+ active players working to develop 24+ pipeline therapies for primary biliary cirrhosis treatment.
- Key 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 are evaluating new primary biliary cirrhosis drugs to improve the treatment landscape.
- 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 are under different phases of primary biliary cirrhosis clinical trials.
- 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).
Request a sample and discover the recent advances in primary biliary cirrhosis treatment drugs @ Primary Biliary Cirrhosis Pipeline Report
The primary biliary cirrhosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage primary biliary cirrhosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the primary biliary cirrhosis clinical trial landscape.
Primary Biliary Cirrhosis Overview
Primary biliary cirrhosis (PBC) is an autoimmune-related chronic and slowly progressive cholestatic liver disease characterized by intrahepatic bile duct injury that can lead to liver failure. At the time of primary biliary cirrhosis diagnosis, most patients are in their fifth to seventh decades of life, and 90% are female.
PBC does not always cause symptoms, but some people may experience bone and joint aches, fatigue (extreme tiredness), itchy skin, dry eyes and mouth, and pain or discomfort in their upper right tummy. Most patients are asymptomatic at the time of diagnosis; however, some patients present with fatigue and pruritus.
A combination of clinical features, an abnormal liver biochemical pattern in a cholestatic picture that persists for more than six months, and the presence of detectable antimitochondrial antibodies (AMA) in serum are used to make the primary biliary cirrhosis diagnosis.
Find out more about primary biliary cirrhosis treatment drugs @ Drugs for Primary Biliary Cirrhosis Treatment
A snapshot of the Primary Biliary Cirrhosis Pipeline Drugs mentioned in the report:
| Drugs | Company | Phase | MoA | RoA |
| Elafibranor | Genfit | Phase III | Antioxidants; Peroxisome proliferator-activated receptor alpha agonists | Oral |
| Seladelpar | CymaBay Therapeutics | Phase III | C-reactive protein inhibitors; Peroxisome proliferator-activated receptor delta agonists | Oral |
| Bezafibrate/obeticholic acid | Intercept Pharmaceuticals | Phase II | Farnesoid X-activated receptor agonists; Peroxisome proliferator-activated receptor alpha agonists; Peroxisome proliferator-activated receptor delta agonists; Peroxisome proliferator-activated receptor gamma agonists | Oral |
| CNP-104 | Cour Pharmaceutical | Phase II | Immunomodulators | Intravenous |
| ASC42 | Gannex Pharma | Phase II | Farnesoid X-activated receptor agonists; Hepatitis B surface antigen expression inhibitors; RNA inhibitors | Oral |
| OP-724 | Ohara Pharmaceutical | Phase I | Beta catenin inhibitors; CREB-binding protein inhibitors; Wnt signalling pathway inhibitors | Intravenous |
| PDC-E2 | Selecta Biosciences | Preclinical | NA | NA |
Learn more about the emerging primary biliary cirrhosis pipeline therapies @ Primary Biliary Cirrhosis Clinical Trials
Primary Biliary Cirrhosis Therapeutics Assessment
The primary biliary cirrhosis pipeline report proffers an integral view of the primary biliary cirrhosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Primary Biliary Cirrhosis Pipeline Report
- Coverage: Global
- Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
- Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal
- Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
- Therapeutics Assessment By Mechanism of Action: Antioxidants; C-reactive protein inhibitors; Peroxisome proliferator-activated receptor delta agonists, Farnesoid X-activated receptor agonists; Peroxisome proliferator-activated receptor alpha agonists; Peroxisome proliferator-activated receptor gamma agonists, Immunomodulators, Farnesoid X-activated receptor agonists; Hepatitis B surface antigen expression inhibitors; RNA inhibitors, Beta catenin inhibitors; CREB-binding protein inhibitors; Wnt signalling pathway inhibitors
- Key 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
- Key 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
Dive deep into rich insights for new drugs for primary biliary cirrhosis treatment, visit @ Primary Biliary Cirrhosis Drugs
Table of Contents
| 1. | Primary Biliary Cirrhosis Pipeline Report Introduction |
| 2. | Primary Biliary Cirrhosis Pipeline Report Executive Summary |
| 3. | Primary Biliary Cirrhosis Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Primary Biliary Cirrhosis Clinical Trial Therapeutics |
| 6. | Primary Biliary Cirrhosis Pipeline: Late Stage Products (Pre-registration) |
| 7. | Primary Biliary Cirrhosis Pipeline: Late Stage Products (Phase III) |
| 7.1 | Elafibranor: Genfit |
| 8. | Primary Biliary Cirrhosis Pipeline: Mid Stage Products (Phase II) |
| 8.1 | CNP-104: Cour Pharmaceutical |
| 9. | Primary Biliary Cirrhosis Pipeline: Early Stage Products (Phase I) |
| 9.1 | OP-724: Ohara Pharmaceutical |
| 10. | Primary Biliary Cirrhosis Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the Primary Biliary Cirrhosis Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the Primary Biliary Cirrhosis Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the primary biliary cirrhosis pipeline therapeutics, reach out @ Primary Biliary Cirrhosis Treatment Drugs
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