Sjogren’s Syndrome Pipeline Insights, 2020

Sjogren's Syndrome Pipeline Insights, 2020

“DelveInsight”
Sjogren’s Syndrome Pipeline Insight, 2020 report by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects across the Sjogren’s Syndrome market. A detailed picture of the Sjogren’s Syndrome pipeline landscape is provided, which includes the disease overview and Sjogren’s Syndrome treatment guidelines.

Sjogren’s Syndrome of pipeline development activities

The report provides insights into: 

  • All of the companies that are developing therapies for the treatment of Sjogren’s Syndrome 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 Sjogren’s Syndrome treatment.
  • Sjogren’s Syndrome 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. 

Scope of Sjogren’s Syndrome Report

  • The Sjogren’s Syndrome 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 Sjogren’s Syndrome across the complete product development cycle, including all clinical and nonclinical stages.
  • It comprises of detailed profiles of Sjogren’s Syndrome therapeutic products with key coverage of developmental activities, including technology, collaborations, licensing, mergers and acquisition, funding, designations and other product-related details
  • Detailed Sjogren’s Syndrome 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 Sjogren’s Syndrome.

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Several companies are working robustly on developing many new therapies, such as Belimumab (GlaxoSmithKline), RSLV-132 (Resolve Therapeutics), VAY736 (Novartis/MorphoSys), CFZ533 (Novartis), LOU-064 (Novartis), Filgotinib (Galapagos NV /Gilead Sciences), VIB7734 (Viela Bio), GS-9876 (Gilead Sciences), Lacripep (TearSolutions), Abatacept (Bristol Myers Squibb), RO5459072 (Roche), Immupharma and others for the treatment of Sjogren’s syndrome. The mid-stage pipeline is crowded, with several potential therapies with the imminent attention of big pharmaceutical companies for this market space.

VAY736 (Ianalumab) (Novartis/MorphoSys) is a novel, subcutaneous, defucosylated, monoclonal antibody, that targets human B cell-activating factor (BAFF). It is engineered to prevent BAFF signaling and effectively eliminate B cells from circulation in vivo by antibody-dependent cellular cytotoxicity (ADCC), providing a dual mode of action. The molecule is being developed by the Novartis in partnership with MorphoSys as an antibody-based therapy. It is currently in Phase II clinical studies for the treatment of moderate to severe Primary Sjögren’s Syndrome. The drug has met the primary endpoint assessing ESSDAI, showing statistically significant dose-response for Ianalumab with clinically important improvement in the results presented in 2019 ACR/ARP Annual Meeting. 

Along with Ianalumab, Novartis also has another two potential candidates Iscalimab and LOU-064 being under development for the treatment of Sjögren’s Syndrome and all are having a different mechanism of actions, providing an edge to compete with others.

Iscalimab (CFZ533) (Novartis) is a novel monoclonal antibody that potently and selectively blocks CD40, a co-stimulatory pathway involved in the activation of immune B-cells, implicated in Sjögren’s syndrome pathogenesis. The molecule is being studied in Phase II clinical trials with Primary Sjögren’s Syndrome who experience systemic manifestations of the disease. The intravenous Iscalimab experienced a mean reduction in overall disease activity of 5.2 points on the ESSDAI score and established primary efficacy and cleared the pathway for future studies.

LOU-064 (Novartis) is being developed as novel covalent BTK inhibitor that acts as a potential therapy for B-cell-driven autoimmune diseases including Sjögren’s syndrome. The oral formulation showed rapid absorption, with a fast onset of action and sustained blood BTK occupancy and blood B cell inhibition. Based on these results, Novartis has started Phase II (LOUiSSe) studies for the treatment of moderate to severe Sjögren’s Syndrome.

Belimumab (GlaxoSmithKline) is a monoclonal antibody, designed to target and inhibit B-lymphocyte stimulator (BLyS)-specific inhibitor, which will be able to reduce B-cell mediated immunity and the autoimmune response. It has been approved for the treatment of SLE and the mechanism of action has shown to be effective in the treatment of Sjögren’s syndrome, as it is characterized by an increase in BAFF (BLyS) levels and resulting B cell hyperactivity. Based on this rationale, currently, GSK is evaluating. 

Table of contents

1. Report Introduction

2. Sjogren’s Syndrome 

2.1. Overview

2.2. History 

2.3. Sjogren’s Syndrome Symptoms

2.4. Causes

2.5.Pathophysiology

2.6. Sjogren’s Syndrome Diagnosis 

2.6.1. Diagnostic Guidelines

3. Sjogren’s Syndrome Current Treatment Patterns

3.1. Sjogren’s Syndrome Treatment Guidelines

4. Sjogren’s Syndrome – DelveInsight’s Analytical Perspective

4.1. In-depth Commercial Assessment

4.1.1. Sjogren’s Syndrome companies collaborations, Licensing, Acquisition -Deal Value Trends

4.1.1.1. Assessment Summary

4.1.2. Sjogren’s Syndrome Collaboration Deals

4.1.2.1. Company-Company Collaborations (Licensing / Partnering) Analysis

4.1.2.2. Company-University Collaborations (Licensing / Partnering) Analysis

4.1.2.3. Sjogren’s Syndrome Acquisition Analysis

5. Sjogren’s Syndrome Therapeutic Assessment

5.1. Clinical Assessment of Pipeline Drugs 

5.1.1. Assessment by Phase of Development

5.1.2. Assessment by Product Type (Mono / Combination)

5.1.2.1. Assessment by Stage and Product Type

5.1.3. Assessment by Route of Administration

5.1.3.1. Assessment by Stage and Route of Administration

5.1.4. Assessment by Molecule Type

5.1.4.1. Assessment by Stage and Molecule Type

5.1.5. Assessment by MOA

5.1.5.1. Assessment by Stage and MOA

5.1.6. Assessment by Target

5.1.6.1. Assessment by Stage and Target

6. Sjogren’s Syndrome Late Stage Products (Phase-III)

7. Sjogren’s Syndrome 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. Sjogren’s Syndrome Discontinued Products

13. Sjogren’s Syndrome Product Profiles

13.1. Drug Name: Company 

13.1.1. Product Description

13.1.1.1. Product Overview

13.1.1.2. Mechanism of action

13.1.2. Research and Development

13.1.2.1. Clinical Studies

13.1.3. Product Development Activities

13.1.3.1. Collaboration

13.1.3.2. Agreements

13.1.3.3. Acquisition 

13.1.3.4. Patent Detail

13.1.4. Tabulated Product Summary

13.1.4.1. General Description Table

14. Sjogren’s Syndrome Key Companies

15. Sjogren’s Syndrome Key Products

16. Dormant and Discontinued Products

16.1. Dormant Products

16.1.1. Reasons for being dormant

16.2. Discontinued Products 

16.2.1. Reasons for the discontinuation

17. Sjogren’s Syndrome Unmet Needs

18. Sjogren’s Syndrome Future Perspectives

19. Sjogren’s Syndrome Analyst Review  

20. Appendix

21. Report Methodology

21.1. Secondary Research

 

21.2. Expert Panel Validation 

VAY736 (Ianalumab) (Novartis/MorphoSys) is a novel, subcutaneous, defucosylated, monoclonal antibody, that targets human B cell-activating factor (BAFF). It is engineered to prevent BAFF signaling and effectively eliminate B cells from circulation in vivo by antibody-dependent cellular cytotoxicity (ADCC), providing a dual mode of action. The molecule is being developed by the Novartis in partnership with MorphoSys as an antibody-based therapy. It is currently in Phase II clinical studies for the treatment of moderate to severe Primary Sjögren’s Syndrome. The drug has met the primary endpoint assessing ESSDAI, showing statistically significant dose-response for Ianalumab with clinically important improvement in the results presented in 2019 ACR/ARP Annual Meeting.

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