Sjogren's syndrome - Pipeline Insight, 2024

This “Sjogren’s syndrome- Pipeline Insight, 2024” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Sjogren’s syndrome 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.

Geography Covered

• Global coverage

Sjogren’s syndrome: Understanding

Sjogren’s syndrome: Overview

Sjogren’s syndrome (SS) is a chronic autoimmune disease with a specific predisposition for causing inflammation of the exocrine glands, predominantly the salivary and lacrimal glands, including the nose, upper respiratory tract, oropharynx, and, in women, the vagina. In SS, the immune system inappropriately attacks various cells, leading to activation of the various pathways, and resulting in inflammation. The main consequence of this inflammation is the development of sicca symptoms due to damage to the salivary and tear glands, such as dryness of the mucosal surfaces, principally in the mouth and eyes. If cytokines, chemokines and autoantibodies are expressed by the epithelium of the exocrine glands: Increased levels of cytokines, chemokine, and autoantibodies expressed by the epithelium of the exocrine glands (such as the salivary and lacrimal glands) lead to chronic inflammation and the eventual loss of their physiological functions.

SS is mainly classified into two types: primary SS and secondary SS. Primary SS occurs in the absence of another original rheumatic disorder. In contrast, secondary SS is related to another underlying rheumatic disease or systemic autoimmune disease (mainly systemic lupus erythematosus [SLE], rheumatoid arthritis [RA], or scleroderma) and is rarely used in patients with concomitant organ-specific autoimmune diseases. However, this terminology is under debate, and standardized guidelines to differentiate them are currently lacking. In fact, the distinction between primary and secondary (or associated) SS reflects only the frequently reported clinical situation of the coexistence or overlap of SS in patients with other autoimmune diseases. However, either ‘primary’ or ‘secondary’ patients receive the same therapeutic management.

The characteristic lesion of Sjogren’s syndrome is focal lymphocytic sialadenitis (FLS). FLS is a lesion of the exocrine glands. Foci of lymphocyte-rich mononuclear cells infiltrate exocrine glandular tissue adjacent to blood vessels and excretory ducts. The foci are comprised predominantly of T lymphocytes. However, B lymphocytes, plasma cells, and other cell types are seen. With a more severe disease, the foci may become confluent. The infiltrating mononuclear cells, humoral factors such as antibodies and cytokines, or both, are hypothesized to cause exocrine gland dysfunction resulting in diminished tear production by the lacrimal glands and diminished saliva production by the salivary glands. Also, exocrine glands outside the head and neck may be involved resulting in skin, tracheobronchial and vaginal dryness as well as lung and kidney dysfunction. Rarely, the malignant transformation of B lymphocytes can result in non-Hodgkin lymphoma. Immune complexes may deposit in skin, joints, and other organs, resulting in a systemic vasculitis.

Sjogren syndrome is managed by replacing moisture at affected glandular sites and diminishing the autoimmune response locally as well as systemically. Autologous serum eye drops are a promising modality in the dry-eye treatment. However, their preparation is quite complex and costly and their use should be limited to selected cases, mainly to patients intolerant to artificial tears or with treatment-resistant KCS. Serum drops are totally nonallergenic and have biochemical properties similar to those of normal tears. Furthermore, serum drops support conjunctival epithelium with vitamins, fibronectin and growth factors which may stimulate its proliferation and repair. From this point of view, platelet releasate seems to have a better growth factor concentration and seems to be a promising new treatment for dry eye.

Sjogren’s syndrome- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Sjogren’s syndrome pipeline landscape is provided which includes the disease overview and Sjogren’s syndrome treatment guidelines. The assessment part of the report embraces, in depth Sjogren’s syndrome commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Sjogren’s syndrome collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Sjogren’s syndrome R&D. The therapies under development are focused on novel approaches to treat/improve Sjogren’s syndrome.

Sjogren’s syndrome Emerging Drugs Chapters

This segment of the Sjogren’s syndrome report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Sjogren’s syndrome Emerging Drugs

VAY736: Novartis VAY736 (ianalumab) is a novel, intravenous, defucosylated, human IgG1/? monoclonal antibody that targets the human B cell-activating factor (BAFF) of the TNF family. The BAFF receptor is predominantly expressed on B cells and is critically involved in B cell maturation, activation, and survival. VAY736 targets the BAFF receptor and competitively inhibits BAFF binding to BAFF-R, thereby blocking BAFF-R-mediated signaling in B cells. It is also engineered to effectively eliminate B cells from circulation in vivo by antibody-dependent cellular cytotoxicity (ADCC). The ADCC activity of ianalumab is greatly enhanced by eliminating fucose residues from the carbohydrate moiety attached to the Fc part of the antibody. The molecule is being developed by Novartis in partnership with MorphoSys as an antibody-based therapy. The drug is currently in Phase III clinical studies for the treatment of Sjögren’s Syndrome(SS).

VIB4920: Horizon Therapeutics VIB4920 is a fusion protein developed by Horizon therapeutics, designed to bind to CD40L on activated T-cells, blocking their interaction with CD40-expressing B-cells. According to the company, this approach could inhibit the stimulation of dendritic cells and monocytes, thereby reducing the production of molecules that cause inflammation endemic to T- and B-cell-driven diseases. Currently, the drug is in the Phase II stage of its development for the treatment of Sjögren’s Syndrome (SS).

Sjogren’s syndrome: Therapeutic Assessment

This segment of the report provides insights about the different Sjogren’s syndrome drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Sjogren’s syndrome

• There are approx. 20+ key companies which are developing the therapies for Sjogren’s syndrome. The companies which have their Sjogren’s syndrome drug candidates in the most advanced stage, i.e. phase III include, Novartis.

Phases

This report covers around 25+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Sjogren’s syndrome pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Sjogren’s syndrome: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Sjogren’s syndrome therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Sjogren’s syndrome drugs.

Sjogren’s syndrome Report Insights

• Sjogren’s syndrome Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Sjogren’s syndrome Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Sjogren’s syndrome drugs?
• How many Sjogren’s syndrome drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Sjogren’s syndrome?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Sjogren’s syndrome 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 Sjogren’s syndrome and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Novartis
• Horizon Therapeutics
• Bristol-Myers Squibb
• Rise Therapeutics
• Resolve Therapeutics
• Dompe Farmaceutici

Key Products

• VAY736
• VIB4920
• BMS-986325
• R-2487
• RSLV-132
• Cenegermin

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