Systemic Lupus Erythematosus - Pipeline Insight, 2024

This “Systemic Lupus Erythematosus - Pipeline Insight, 2024” report provides comprehensive insights about 120+ companies and 140+ pipeline drugs in Systemic Lupus Erythematosus 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

Systemic Lupus Erythematosus: Understanding

Systemic Lupus Erythematosus: Overview

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, including the skin, joints, kidneys, heart, and lungs. SLE results from the immune system attacking healthy tissue due to an inability to distinguish between the body’s cells and foreign pathogens. This process triggers widespread inflammation and can lead to significant morbidity, making SLE a highly variable and complex disease to diagnose, treat, and manage. The condition disproportionately affects women, particularly of childbearing age, and is more common in certain ethnic groups, including African Americans, Hispanics, and Asians, which indicates both hormonal and genetic factors may contribute to disease susceptibility.

The pathogenesis of SLE is multifactorial, with genetic, environmental, and immunologic components. Researchers have identified certain genetic variations associated with an increased risk of SLE, including those involved in immune regulation, response to infection, and inflammation pathways. Environmental triggers such as ultraviolet (UV) radiation, certain medications, infections, and stress may also exacerbate symptoms or initiate disease onset in genetically predisposed individuals. Immunologically, SLE is marked by the presence of autoantibodies, particularly antinuclear antibodies (ANAs) and anti-double-stranded DNA (dsDNA) antibodies, which target the body’s own nuclear material. These antibodies form immune complexes that can deposit in various tissues, leading to further inflammation and tissue damage.

The clinical presentation of SLE is highly diverse, with symptoms that can fluctuate between periods of exacerbation, known as flares, and remission. Common symptoms include fatigue, fever, joint pain, and skin rashes such as the characteristic butterfly-shaped rash across the cheeks and nose. More severe complications may include nephritis, which can lead to kidney failure, central nervous system involvement causing cognitive and psychiatric symptoms, and cardiovascular issues that increase the risk of heart disease. This variability in presentation and disease course makes diagnosis challenging, often requiring a combination of clinical evaluation, laboratory tests, and imaging studies. The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) have established classification criteria to aid in diagnosis, which considers symptoms, serology, and organ involvement.

Management of SLE requires a multidisciplinary approach and focuses on controlling symptoms, preventing flares, and minimizing organ damage. Treatment often involves a combination of lifestyle changes, patient education, and pharmacologic interventions aimed at suppressing immune activity and controlling inflammation. Patients are encouraged to avoid sun exposure, maintain a healthy lifestyle, and adhere to regular follow-ups. The prognosis for SLE has improved significantly over recent decades, with advances in early diagnosis and supportive care, although it remains a lifelong disease with the potential for serious complications. Enhanced understanding of the underlying immunologic pathways continues to drive research efforts, with the aim of developing more targeted therapies that improve patient outcomes and quality of life.

"Systemic Lupus Erythematosus - Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Systemic Lupus Erythematosus pipeline landscape is provided which includes the disease overview and Systemic Lupus Erythematosus treatment guidelines. The assessment part of the report embraces, in depth Systemic Lupus Erythematosus 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, Systemic Lupus Erythematosus 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 Systemic Lupus Erythematosus R&D. The therapies under development are focused on novel approaches to treat/improve Systemic Lupus Erythematosus.

Systemic Lupus Erythematosus Emerging Drugs Chapters

This segment of the Systemic Lupus Erythematosus report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, 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.

Systemic Lupus Erythematosus Emerging Drugs

BIIB059: Biogen

BIIB059, also known as Litifilimab, is a humanized IgG1 monoclonal antibody developed by Biogen, targeting the blood dendritic cell antigen 2 (BDCA2). This antibody is primarily investigated for its therapeutic potential in treating systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), both of which are chronic autoimmune diseases. BIIB059 specifically binds to BDCA2, a receptor found exclusively on plasmacytoid dendritic cells (pDCs). By binding to this receptor, BIIB059 inhibits the production of type-I interferon (IFN-I) and other pro-inflammatory cytokines, which are implicated in the pathogenesis of lupus. This mechanism is crucial as pDCs are known to produce large amounts of IFN-I in response to immune stimuli, contributing to the inflammatory processes seen in lupus patients. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Systemic Lupus Erythematosus.

Cenerimod: Idorsia Pharmaceuticals

Cenerimod, developed by Idorsia Pharmaceuticals, is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that is being investigated primarily for the treatment of systemic lupus erythematosus (SLE). This novel oral medication aims to address the unmet medical needs in SLE, a chronic autoimmune disease characterized by significant morbidity and limited treatment options. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Systemic Lupus Erythematosus.

ABBV 599: AbbVie

ABBV-599, developed by AbbVie, is a novel fixed-dose combination therapy that combines two well-known agents: elsubrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, and upadacitinib, a Janus kinase (JAK) inhibitor. This combination is primarily being investigated for the treatment of autoimmune diseases, particularly systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). Currently, the drug is in the Phase II stage of development to treat Systemic Lupus Erythematosus.

Arscimed: Biosenic

Arscimed, developed by BioSenic, is an innovative drug utilizing arsenic trioxide to target autoimmune diseases at the source of the immune cascade. This therapy is particularly focused on conditions such as chronic graft-versus-host disease (cGVHD), systemic lupus erythematosus (SLE), and systemic sclerosis. Currently, the drug is in the Phase II stage of development to treat Systemic Lupus Erythematosus.

Mosunetuzumab: Roche

Mosunetuzumab, a bispecific antibody developed by Roche, is currently being evaluated for its potential use in treating systemic lupus erythematosus (SLE), a chronic autoimmune disease. This investigational therapy targets both CD20 on B cells and CD3 on T cells, aiming to enhance immune response against autoantibody-producing B cells. Currently, the drug is in the Phase I stage of development to treat Systemic Lupus Erythematosus.

Systemic Lupus Erythematosus: Therapeutic Assessment

This segment of the report provides insights about the different Systemic Lupus Erythematosus drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Systemic Lupus Erythematosus

There are approx. 120+ key companies which are developing the therapies for Systemic Lupus Erythematosus. The companies which have their Systemic Lupus Erythematosus drug candidates in the most advanced stage, i.e. Phase III include, Biogen and Idorsia Pharmaceuticals.

Phases

The report covers around 140+ 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

Systemic Lupus Erythematosus 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.

Systemic Lupus Erythematosus: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Systemic Lupus Erythematosus 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 Systemic Lupus Erythematosus drugs.

Systemic Lupus Erythematosus Report Insights

• Systemic Lupus Erythematosus Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Biogen
• Idorsia Pharmaceuticals
• AbbVie
• Biosenic
• Roche
• Eisai
• Daiichi Sankyo Company
• Carna Bioscience
• Asahi Kasei Pharma
• Sanofi
• Alpine Immune Sciences
• Novartis Pharmaceuticals
• Sana Biotechnology

Key Products

• BIIB059
• Cenerimod
• ABBV 599
• Arscimed
• Mosunetuzumab
• E6742
• DS-7011a
• AS-0871
• SBI-3150
• SAR441344
• ALPN-101
• Rapcabtagene autoleucel
• SC291

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