Lupus Nephritis - Pipeline Insight, 2024

This “Lupus Nephritis - Pipeline Insight, 2024” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Lupus Nephritis 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

Lupus Nephritis: Understanding

Lupus Nephritis: Overview

Lupus Nephritis (LN) is one of the most severe organ manifestations of systemic lupus erythematosus (SLE), which is an autoimmune disorder leading to the loss of immune tolerance of endogenous nuclear material, resulting in systemic autoimmunity that causes damage to various tissues and organs. According to the National Kidney Foundation, Lupus nephritis (LN) is a form of glomerulonephritis that causes inflammation (swelling or scarring) of the small blood vessels that filter wastes in the kidney (glomeruli) and sometimes the kidney itself. Histologically, LN is classified into six distinct classes, representing different manifestations and severity of renal involvement in SLE.

Lupus nephritis can cause permanent kidney damage, called chronic kidney disease or CKD. The most serious type of lupus nephritis is proliferative nephritis, which can cause scarring of the kidneys. These scars can damage the kidneys and prevent them from working properly. Chronic kidney disease that gets worse and causes the kidneys to stop working is called kidney failure or end-stage renal disease (ESRD). The major risk factors associated with LN are gender, ethnicity, genetic factors, and environmental factors. LN is typically treated with drugs that block the body’s immune system. These drugs include immunosuppressive drugs such as glucocorticoids, and cyclophosphamide or mycophenolate mofetil (MMF).

Lupus nephritis is a type-3 hypersensitivity reaction. This occurs when immune complexes are formed. Autoimmunity plays a significant role in the development of lupus nephritis leading to the production of autoantibodies that are directed against nuclear elements. The characteristics of these autoantibodies in relevance to lupus nephritis are: Anti-ds DNA antibodies may cross-react with the glomerular basement membrane; higher-affinity autoantibodies may result in intravascular immune complexes that get deposited in glomeruli; cationic autoantibodies have a greater affinity for the anionic basement membrane and activation of complements by autoantibodies of certainisotypes.

These autoantibodies make immune complexes within the vessels that are deposited in glomeruli. Alternatively, autoantibodies may form immune complexes in situ by binding to antigens that are already located in the glomerular basement membrane. Immune complexes induce an inflammatory response by the activation of the complement system and recruitment of inflammatory cells. Glomerular thrombosis is another phenomenon that plays a part in the pathogenesis of lupus nephritis particularly in patients with antiphospholipid syndrome and is believed to be the result of an interaction between antibodies and negatively charged phospholipid-proteins. Azzouz and colleagues analyzed that specific strains of a gut commensal may add to the pathogenesis of lupus nephritis. When patients with SLE were stratified according to organ involvement, ones with a history of renal impairment showed a great number of RG-specific amplicon sequence variants as opposed to those who had no renal disease
The introduction of corticosteroids and later, cyclophosphamide dramatically improved survival in patients with proliferative lupus nephritis, and combined administration of these agents became the standard-of-care treatment for this disease. However, treatment failures were still common and the rate of progression to ESRD remained unacceptably high. Additionally, treatment was associated with significant morbidity. Therefore, as patient survival improved, the goals for advancing lupus nephritis treatment shifted to identifying therapies that could improve long-term renal outcomes and minimize treatment-related toxicity. Unfortunately, progress has been slow and the current approaches to the management of lupus nephritis continue to rely on high-dose corticosteroids plus a broad-spectrum immunosuppressive agent. Over the past decade, an improved understanding of lupus nephritis pathogenesis fueled several clinical trials of novel drugs, but none have been found to be superior to the combination of a cytotoxic agent and corticosteroids. Despite these trial failures, efforts to translate mechanistic advances into new treatment approaches continue.

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

Lupus Nephritis Emerging Drugs Chapters

This segment of the Lupus Nephritis 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.

Lupus Nephritis Emerging Drugs

Obinutuzumab: Roche Gazyva (Obinutuzumab) is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. Gazyva is part of a collaboration between Genentech and Biogen. Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers. In September 2019, Roche announced that the US FDA granted Breakthrough Therapy Designation (BTD) to Gazyva (Obinutuzumab) for adults with lupus nephritis. Currently, Obinutuzumab is in the Phase III clinical stage of its development for the treatment of lupusnephritis.

Daxdilimab: Horizon Therapeutics Daxdilimab is an anti-ILT7 human monoclonal antibody that depletes certain dendritic cells. Depleting these cells may interrupt the cycle of inflammation that causes tissue damage in a variety of autoimmune conditions. Horizon is also investigating daxdilimab in alopecia areata, discoid lupus erythematosus, systemic lupus erythematosus and plans to investigate it in dermatomyositis or anti-synthetase inflammatory myositis. Currently, the drug is in the Phase II clinical stage of its development for the treatment of lupus nephritis.

Itolizumab: Equillium Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive several immuno-inflammatory diseases. This unique molecule holds the potential for multiple high-value indications. As an innovation-led organization committed to bringing novel therapeutics to the market to address unmet patient needs across the world, Biocon out-licensed Itolizumab to U.S.-based biotechnology company Equillium in 2017 for them to develop this molecule for the treatment of severe autoimmune and inflammatory disorders. Equillium is currently developing the drug in the Phase I clinical stage of its development for the treatment of lupusnephritis.

Lupus Nephritis: Therapeutic Assessment

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

Major Players in Lupus Nephritis

• There are approx. 20+ key companies which are developing the therapies for Lupus Nephritis. The companies which have their Lupus Nephritis drug candidates in the most advanced stage, i.e. Phase III include, Roche.

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

Lupus Nephritis 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.

Lupus Nephritis: Pipeline Development Activities

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

Lupus Nephritis Report Insights

• Lupus Nephritis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Roche
• Horizon Therapeutics
• Equillium
• Argenx
• AstraZeneca
• Novartis
• RemeGen
• Annexon

Key Products

• Obinutuzumab
• Daxdilimab
• Itolizumab
• Efgartigimod
• Anifrolumab
• Telitacicept
• Secukinumab
• ANX009

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