New York, USA, April 27, 2022 (GLOBE NEWSWIRE) -- Primary Sclerosing Cholangitis Pipeline: Therapeutic Assessment, Emerging Drugs and Growth Prospects Analysis | DelveInsight
Primary Sclerosing Cholangitis is a rare disease that has an impact on the bile duct. More than 25+ companies are involved in product development in different stages of development including Gilead sciences, Pliant Therapeutics, Mirum Pharmaceuticals, Chemomab Therapeutics, Gannex Pharma, and several others. The rising prevalence of liver diseases globally is advancing the research and development activities to develop the potential treatment for Primary Sclerosing Cholangitis.
DelveInsight’s 'Primary Sclerosing Cholangitis (PSC) Pipeline Insight 2022' report provides comprehensive global coverage of available, marketed, and pipeline Primary Sclerosing Cholangitis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Primary Sclerosing Cholangitis pipeline domain.
Key Takeaways from the Primary Sclerosing Cholangitis Pipeline Report
- DelveInsight’s Primary Sclerosing Cholangitis Pipeline report depicts a robust space with 25+ active players working to develop 25+ pipeline therapies for Primary Sclerosing Cholangitis treatment.
- The major Primary Sclerosing Cholangitis companies include Gilead Sciences, Immunic, Dr Falk Pharma, Pliant Therapeutics, CymaBay Therapeutics, SCOHIA PHARMA, Albireo Pharma, Sirnaomics, Morphic Therapeutic, Mirum Pharmaceuticals, Chemomab Therapeutics, Cascade Pharmaceuticals, Qing Bile Therapeutics, Engitix, BiomX, COUR Pharmaceutical, Avolynt, Inc., Selecta Biosciences, Gannex Pharma, LISCure Bioscience, Genfit, HighTide Therapeutics, Calliditas Therapeutics, Invea Therapeutics, and others are developing novel drug candidates to improve the Primary Sclerosing Cholangitis treatment landscape.
- Key Primary Sclerosing Cholangitis pipeline therapies in various stages of development include Cilofexor, Volixibat, CM 101, CS0159, QBT-002, PLN-74809, Research programme: anti-fibrotic therapeutics, STP707, CNP-104, AVO-1681, ASC42, Seladelpar, HTD-1801, Setanaxib, SCO-240 and others.
- In January 2022, Engitix Builded a Liver Disease Pipeline with €48M Series A round and drug discovery partnership with the Milan-based Dompé Farmaceutici. The proceeds from Engitix’s Series A round will bankroll the development of the company’s tissue models for use in drug discovery. Additionally, the investment will fuel the preclinical development of Engitix’s drug pipeline, with a focus on treating liver diseases including primary sclerosing cholangitis and liver cancer. The first candidate is expected to reach phase I testing by 2025.
- In February 2022, Siranomics received the "safe to proceed" letter from the US Food and Drug Administration (FDA) for the Company's investigational new drug (IND) application for STP707, its lead siRNA (small interfering RNA) drug candidate in Primary Sclerosing Cholangiti . The Company anticipates initiating Phase I study in the second quarter of 2022 to evaluate the safety, tolerability, and pharmacokinetics of STP707, administered intravenously in healthy volunteers.
- In January 2022, US FDA granted Fast Track Designation to CNP-104 for the treatment of Primary Biliary Cholangitis. In November 2021, Ironwood Pharmaceuticals signed an Option Agreement to Acquire an Exclusive License with COUR Pharmaceuticals to Develop and Commercialize CNP-104 for the Treatment of Primary Biliary Cholangitis in the US.
- In December 2021, Ipsen and GENFIT entered into a long-term strategic partnership for global collaboration between the two companies. The agreement gave Ipsen exclusive worldwide (with the exception of China, Hong Kong, Taiwan, and Macau where Terns Pharmaceuticals holds the exclusive license to develop and commercialize elafibranor) license to develop, manufacture, and commercialize GENFIT’s investigational treatment elafibranor, for people living with Primary Biliary Cholangitis.
- In January 2022, LISCure Biosciences executed a research collaboration agreement with US based-Mayo Clinic for new drug development for rare liver diseases. Under the terms of the agreement, Mayo Clinic and LISCure metabolic disease R&D teams will collaborate on preclinical and clinical studies for rare liver diseases including primary sclerosing cholangitis.
- In April 2022, Gannex Pharma dosed the first patient in Phase II clinical trial of ASC42 to treat patients with primary biliary cholangitis (PBC). Gannex is expected to complete the Phase II trial in 100 patients by the end of 2022. It intends to soon start a Phase III trial in China, the U.S., and the European Union after the completion of the Phase II study in China.
- PLN-74809 being developed by Pliant therapeutics is being investigated in Phase IIa trial in primary sclerosing cholangitis. INTEGRIS-PSC is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 at doses of 40, 80 or 160 mg in approximately 84 PSC patients. Topline data is expected in late 2022 or early 2023.
Request a sample and discover the recent breakthroughs happening in the Primary Sclerosing Cholangitis pipeline landscape @ Primary Sclerosing Cholangitis Pipeline Outlook
The Primary Sclerosing Cholangitis (PSC) pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Primary Sclerosing Cholangitis products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Primary Sclerosing Cholangitis pipeline landscape.
Primary Sclerosing Cholangitis Overview
Primary Sclerosing Cholangitis (PSC) is a chronic, progressive cholestatic liver disorder with an unknown cause. Primary Sclerosing Cholangitis is characterized by inflammation, fibrosis, and stricturing of intrahepatic and/or extrahepatic biliary ducts. Primary Sclerosing Cholangitis is often a progressive condition that leads to cholestasis and liver failure consequences. The Primary Sclerosing Cholangitis types are classified into subgroups: Classic Primary Sclerosing Cholangitis, Small Duct Primary Sclerosing Cholangitis, Primary Sclerosing Cholangitis associated with autoimmune hepatitis.
The Primary Sclerosing Cholangitis causes are unknown. The immune system response to an infection or toxin may cause the disease in persons who are genetically prone to it. Without a liver transplant, the Primary Sclerosing Cholangitis life expectancy is roughly 10 years.
The most common Primary Sclerosing Cholangitis symptoms are fatigue and itchy skin. Other Primary Sclerosing Cholangitis symptoms may include losing weight without trying, a loss of appetite, fever, and abdominal pain. As the disease progresses, individuals may have cirrhosis and liver failure symptoms such as bloating, bruising, bleeding easily, disorientation, difficulty thinking, memory loss, redness in the palms, and swelling in the legs, ankles, or feet. In cholangiography, the presence of numerous and focused regions of stricturing and dilatation of intrahepatic and/or extrahepatic bile ducts is commonly used to make the Primary Sclerosing Cholangitis diagnosis.
The Primary Sclerosing Cholangitis treatment is difficult and complicated. There is currently no known Primary Sclerosing Cholangitis treatment. Ursodeoxycholic acid (UDCA) has been extensively researched as a treatment for Primary Sclerosing Cholangitis patients. The Primary Sclerosing Cholangitis treatment guidelines are contradictory.
Find out more about Primary Sclerosing Cholangitis treatment @ Primary Sclerosing Cholangitis Guidelines
A snapshot of the Primary Sclerosing Cholangitis Pipeline Drugs mentioned in the report:
| Drugs | Company | Phase | MoA | RoA |
| Cilofexor | Gilead Sciences | Phase III | Farnesoid X-activated receptor agonists | Oral |
| PLN-74809 | Pliant Therapeutics | Phase II | Integrin alphavbeta1 inhibitors | Oral |
| Volixibat | Mirum Pharmaceuticals | Phase II | Sodium-bile acid cotransporter inhibitors | Oral |
| CM 101 | Chemomab Therapeutics | Phase II | Chemokine CCL24 inhibitors | Intravenous |
| CS0159 | Cascade Pharmaceuticals | Phase I | NA | Oral |
| A-3907 | Albireo Pharma | Phase I | Sodium-bile acid cotransporter inhibitors | Oral |
| QBT-002 | Qing Bile Therapeutics | Preclinical | NA | NA |
| Research programme: anti-fibrotic therapeutics | Engitix | Discovery | NA | NA |
Learn more about the novel and emerging Primary Sclerosing Cholangitis pipeline therapies @ Primary Sclerosing Cholangitis Clinical Trials
Primary Sclerosing Cholangitis Therapeutics Assessment
The Primary Sclerosing Cholangitis Pipeline report proffers an integral view of the Primary Sclerosing Cholangitis emerging novel therapies segmented by Stage, Product Type, Molecule Type, Mechanism of Action, and Route of Administration.
Scope of the Primary Sclerosing Cholangitis 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: Oral, Parenteral, Topical, Intravitreal, Subretinal
- Therapeutics Assessment By Molecule Type: Gene therapies, Small molecule, Polymers, Peptides, Monoclonal antibodies
- Therapeutics Assessment By Mechanism of Action: Farnesoid X-activated receptor agonists, Integrin alphavbeta1 inhibitors, Sodium-bile acid cotransporter inhibitors, C-reactive protein inhibitors, Peroxisome proliferator-activated receptor delta agonists, Cyclo-oxygenase 2 inhibitors, RNA interference, Transforming growth factor beta1 expression inhibitors
- Key Primary Sclerosing Cholangitis Companies: Gilead Sciences, Immunic, Dr Falk Pharma, Pliant Therapeutics, CymaBay Therapeutics, SCOHIA PHARMA, Albireo Pharma, Sirnaomics, Morphic Therapeutic, Mirum Pharmaceuticals, Chemomab Therapeutics, Cascade Pharmaceuticals, Qing Bile Therapeutics, Engitix, BiomX, COUR Pharmaceutical, Avolynt, Inc., Selecta Biosciences, Gannex Pharma, LISCure Bioscience, Genfit, HighTide Therapeutics, Calliditas Therapeutics, Invea Therapeutics and others.
- Key Primary Sclerosing Cholangitis Pipeline Therapies: Cilofexor, Volixibat, CM 101, CS0159, QBT-002, PLN-74809, Research programme: anti-fibrotic therapeutics, STP707, CNP-104, AVO-1681, ASC42, Seladelpar, HTD-1801, Setanaxib, SCO-240 and others.
Dive deep into rich insights for drugs for Primary Sclerosing Cholangitis, visit @ Primary Sclerosing Cholangitis Emerging Therapies
Table of Contents
| 1. | Primary Sclerosing Cholangitis Pipeline Report Introduction |
| 2. | Primary Sclerosing Cholangitis Pipeline Report Executive Summary |
| 3. | Primary Sclerosing Cholangitis Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Primary Sclerosing Cholangitis Pipeline Therapeutics |
| 6. | Primary Sclerosing Cholangitis Pipeline: Late Stage Products (Phase III) |
| 6.1 | Cilofexor: Gilead Sciences |
| 7. | Primary Sclerosing Cholangitis Pipeline: Mid Stage Products (Phase II) |
| 7.1 | PLN-74809: Pliant Therapeutics |
| 8. | Primary Sclerosing Cholangitis Pipeline: Early Stage Products (Phase I) |
| 8.1 | CS0159: Cascade Pharmaceuticals |
| 9. | Primary Sclerosing Cholangitis Pipeline: Early Stage Products (Preclinical and Discovery) |
| 9.1 | QBT-002: Qing Bile Therapeutics |
| 10. | Primary Sclerosing Cholangitis Pipeline Therapeutic Assessment |
| 11. | Inactive Products in the Primary Sclerosing Cholangitis Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the Primary Sclerosing Cholangitis 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 Sclerosing Cholangitis pipeline therapeutics, reach out @ Primary Sclerosing Cholangitis Treatment Guidelines
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