Complement 3 Glomerulopathy Pipeline Insight, 2020 By DelveInsight

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Complement 3 Glomerulopathy Pipeline Insight, 2020 By DelveInsight

(Albany, US) Delveinsight has launched a new report on Complement 3 Glomerulopathy Pipeline

Complement 3 Glomerulopathy Pipeline Insight, 2020 report by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects across the Complement 3 Glomerulopathy market. A detailed picture of the Complement 3 Glomerulopathy pipeline landscape is provided, which includes the disease overview and Complement 3 Glomerulopathy treatment guidelines. The assessment part of the report embraces in-depth Complement 3 Glomerulopathy commercial assessment and clinical assessment of the Complement 3 Glomerulopathy pipeline products from the pre-clinical developmental phase to the marketed phase. In the report, a detailed description of the drug is proffered including mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Complement 3 Glomerulopathy collaborations, licensing, mergers and acquisition, funding, designations, and other product-related details.

Complement 3 glomerulopathy (C3G) was adopted by expert consensus in 2013 to define a group of rare kidneys diseases driven by dysregulation of the complement cascade. It is a type of glomerular disease, characterized by predominant C3 complement component (C3) deposits in the glomeruli in the absence of a significant amount of immunoglobulin and without deposition of C1q and C4.  The term C3G includes dense deposit disease (DDD) and C3 glomerulonephritis (C3GN), which are the two patterns of damage and inflammation in the glomeruli. In other words, the damage and inflammation in the kidney tissue in DDD appear different from that in C3GN when observed under a microscope. People with DDD generally present at a younger age (childhood or adolescence) compared to people with C3GN (adulthood).  In DDD, C3 deposits are bunched up in one area of the glomeruli and appear thick while in case of C3GN, C3 deposits are more spread out and less thick. Progression to end-stage renal disease (ESRD) has been found in 40% of C3G patients, with no detectable difference between those with C3GN versus DDD. Dysregulation of the complement alternative pathway, driven by acquired and/or genetic defects, plays a pathogenetic role in C3G. However, alternative pathway abnormalities are also found in IC-MPGN (immune-complex-MPGN). The most common acquired drivers of C3G are the C3 nephritic factors (C3NeFs),heterogeneous autoantibodies that stabilize the C3 convertase, C3bBb.

 

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Complement 3 Glomerulopathy Pipeline Development

The report provides insights into: 

  • All of the companies that are developing therapies for the treatment of Complement 3 Glomerulopathy with aggregate therapies developed by each company for the same.
  • Different therapeutic candidates segmented into early-stage, mid-stage and late stage of development for the Complement 3 Glomerulopathy treatment.
  • Complement 3 Glomerulopathy key players involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of Complement 3 Glomerulopathy market.
  • The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university web sites and industry-specific third-party sources, etc. 

 

Complement 3 Glomerulopathy Pipeline

The dynamics of C3G market is anticipated to change in the coming years owing to the improvement in the research and development activities so that market will comprise of efficient treatment options. The launch of emerging therapies is expected during the forecast period of 2020-2030..

  • Danicopan (ACH-4471/ ALXN2040) is an investigational, oral, factor D inhibitor, which is designed to treat rare diseases associated with the complement alternative pathway. The drug acts by selectively inhibiting the binding of complement factor C3b from complementing factor D, triggering downstream activation of the AP-mediated terminal pathway. The company is expecting to publish the interim data of its phase II clinical developmental trial for the treatment of C3G in the second quarter of 2020. The company is also expecting to complete danicopan phase II C3G studies and target global regulatory discussions in 2020 itself.
  • In January 2020, Alexion Pharmaceuticals completed acquisition of Achillion Pharmaceuticals, which added two clinical-stage oral small molecule factor D inhibitors including Danicopan to Alexion’s pipeline. The drug has also been granted Orphan Drug Designation by the FDA and the EMA for the treatment of C3G patients. Currently, the drug is being investigated in a phase II trial for C3G in the United States and the United Kingdom.
  • Narsoplimab is a human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. This novel, proprietary drug is designed to prevent complement-mediated inflammation and endothelial damage while leaving intact the respective functions of the other pathways of innate immunity. The drug is currently being assessed in a phase II trial for C3G. In addition to potential intravenous administration, Omeros plans to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection and is also developing small-molecule inhibitors of MASP-2. Based on requests from treating physicians, the company has established a compassionate-use program for OMS721, which is active in both the US and Europe .
  • Apellis’ Pegcetacoplan (APL-2) is an investigational, targeted C3 inhibitor designed to regulate excessive complement activation, which can lead to the onset and progression of many serious diseases. The company plans to disclose the strategy and timing for furtherclinical development of pegcetacoplan for patients with cold agglutinin disease (CAD) and C3G in the second quarter of 2020. In November 2019, positive preliminary results were presented at the American Society of Nephrology (ASN) Kidney Week 2019, and based on these results, Apellis plans to advance the development of APL-2 in C3G. In December 2018, APL-2 was granted Orphan Drug Designation by the FDA for the treatment of C3G. Currently, the drug is being evaluated in phase II clinical developmental trial for patients with C3G.

 

Emerging drugs included in the report

  • Danicopan (ACH-4471/ALXN2040): Alexion Pharmaceuticals
  • Narsoplimab (OMS721): Omeros Corporation
  • Pegcetacoplan (APL-2): Apellis Pharmaceuticals
  • LNP023 (TBD): Novartis Pharmaceuticals

 

 Scope of the Report

  • The Complement 3 Glomerulopathy report provides an overview of therapeutic pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and MOA type for Complement 3 Glomerulopathy across the complete product development cycle, including all clinical and nonclinical stages.
  • It comprises of detailed profiles of Complement 3 Glomerulopathy therapeutic products with key coverage of developmental activities, including technology, collaborations, licensing, mergers and acquisition, funding, designations and other product-related details
  • Detailed Complement 3 Glomerulopathy research and development progress and trial details, results wherever available, are also included in the pipeline study.
  • Coverage of dormant and discontinued pipeline projects along with the reasons if available across Complement 3 Glomerulopathy

 

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 Table of content

1. Report Introduction

2. Complement 3 Glomerulopathy  

3. Complement 3 Glomerulopathy  Current Treatment Patterns

4. Complement 3 Glomerulopathy  – DelveInsight’s Analytical Perspective

5. Therapeutic Assessment

6. Complement 3 Glomerulopathy Late Stage Products (Phase-III)

7. Complement 3 Glomerulopathy Mid Stage Products (Phase-II)

8. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Products

11. Dormant Products

12. Complement 3 Glomerulopathy Discontinued Products

13. Complement 3 Glomerulopathy  Product Profiles

14. Complement 3 Glomerulopathy  Key Companies

15. Complement 3 Glomerulopathy  Key Products

16. Dormant and Discontinued Products

17. Complement 3 Glomerulopathy  Unmet Needs

18. Complement 3 Glomerulopathy  Future Perspectives

19. Complement 3 Glomerulopathy  Analyst Review  

20. Appendix

21. Report Methodology

 

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