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Primary Sclerosing Cholangitis Pipeline| 20+ Key Players & 22+ Pipeline Drugs

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Primary Sclerosing Cholangitis Pipeline| 20+ Key Players & 22+ Pipeline Drugs

November 23
22:48 2022
Primary Sclerosing Cholangitis Pipeline| 20+ Key Players & 22+ Pipeline Drugs

DelveInsight’s, “Primary Sclerosing Cholangitis Pipeline Insight, 2022,” report provides comprehensive insights about 14+ companies and 14+ pipeline drugs in the Primary Sclerosing Cholangitis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

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.
  • The Primary Sclerosing Cholangitis Companies and academics are working to assess challenges and seek opportunities that could influence Primary Sclerosing Cholangitis R&D. The therapies under development are focused on novel approaches to treat/improve Primary Sclerosing Cholangitis.

 

Recent Developmental Activities in the Primary Sclerosing Cholangitis Pipeline

  • 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

 

Primary Sclerosing Cholangitis Overview

Primary sclerosing cholangitis (PSC) is a chronic liver disease characterized by a progressive course of cholestasis with inflammation and fibrosis of the intrahepatic and extrahepatic bile ducts. The condition may lead to cirrhosis of the liver with portal hypertension and end-stage liver disease (ESLD). The main symptoms of primary sclerosing cholangitis (PSC) are feeling tired or weak and having itchy skin. Other symptoms may include losing weight without trying, poor appetite, fever, and pain in the abdomen. The cause of PSC is not known. A diagnosis of primary sclerosing cholangitis is made based upon a thorough clinical evaluation, a detailed patient history, identification of characteristic findings, and a variety of specialized tests. Diagnosis is done by cholangiography (magnetic resonance cholangiopancreatography [MRCP] or endoscopic retrograde cholangiopathy [ERCP]). Treatments for primary sclerosing cholangitis focus on managing complications and monitoring liver damage. Endoscopic surgery to remove blockages and enlarge narrowed bile ducts may be of benefit to help prevent liver deterioration in certain cases. Lost vitamins should be replaced when required to prevent complications related to these deficiencies.

 

Primary Sclerosing Cholangitis Emerging Drugs

GS-9674: Gilead Sciences

GS-9674 (Cilofexor) is an orally active, small molecule based nonsteroidal FXR agonist. The drug is in Phase III clinical studies for the treatment of Primary sclerosing cholangitis. 

IMU-838: Immunic

IMU-838 is a small molecule investigational drug (vidofludimus calcium) under development as an oral tablet formulation for the treatment PSC. The drug is in clinical studies for the treatment of Relapsing-Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Ulcerative Colitis, Crohn’s Disease, and Primary Sclerosing Cholangitis. The drug is in Phase II clinical studies for the treatment of Primary sclerosing cholangitis.

 

Primary Sclerosing Cholangitis Pipeline Therapeutic Analysis

There are approx. 14+ key companies which are developing the therapies for Primary Sclerosing Cholangitis. The companies which have their Primary Sclerosing Cholangitis drug candidates in the most advanced stage, i.e. Phase III include, Gilead Sciences.

 

Find out more about Primary Sclerosing Cholangitis treatment @ Primary Sclerosing Cholangitis Clinical Trials

 

Primary Sclerosing Cholangitis Pipeline 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
  • Primary Sclerosing Cholangitis Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
  • Primary Sclerosing Cholangitis Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
  • Primary Sclerosing Cholangitis Therapeutics Assessment By Route of Administration: Oral, Parenteral, Topical, Intravitreal, Subretinal
  • Primary Sclerosing Cholangitis Therapeutics Assessment By Molecule Type: Gene therapies, Small molecule, Polymers, Peptides, Monoclonal antibodies
  • Primary Sclerosing Cholangitis 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 Content

  1. Introduction
  2. Executive Summary
  3. Primary Sclerosing Cholangitis: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Primary Sclerosing Cholangitis – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. GS-9674: Gilead Sciences
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. IMU-838: Immunic
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. SCO-240: SCOHIA PHARMA
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. MORF 627: Morphic Therapeutic
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Primary Sclerosing Cholangitis Key Companies
  21. Primary Sclerosing Cholangitis Key Products
  22. Primary Sclerosing Cholangitis- Unmet Needs
  23. Primary Sclerosing Cholangitis- Market Drivers and Barriers
  24. Primary Sclerosing Cholangitis- Future Perspectives and Conclusion
  25. Primary Sclerosing Cholangitis Analyst Views
  26. Appendix

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Primary Sclerosing Cholangitis drugs?
  • How many Primary Sclerosing Cholangitis drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Primary Sclerosing Cholangitis?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Primary Sclerosing Cholangitis therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Primary Sclerosing Cholangitis and their status?
  • What are the key designations that have been granted to the emerging drugs?

 

For further information on the Primary Sclerosing Cholangitis pipeline therapeutics, reach out to Primary Sclerosing Cholangitis Treatment Landscape

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