Lupus Nephritis - Pipeline Insight, 2024

This “Lupus Nephritis - Pipeline Insight, 2024” report provides comprehensive insights about 30+ companies and 35+ 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. The overall incidence and prevalence of SLE ranges 7.4-159.4 cases per 100,000 people and from 1.4 to 21.9 %, respectively.

According to 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 kidneys 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 blocks body’s immune system. These drugs include immunosuppressive drugs, such as glucocorticoids, and cyclophosphamide or mycophenolate mofetil (MMF).

A variety of pathogenic mechanisms are involved in pathogenesis of lupus nephritis. The extra renal etiology of systemic lupus is based on a combination of genetic variations that alter the mechanisms that normally ensure immune tolerance to nuclear auto antigens. With the progress of renal immunopathology, tertiary lymphoid tissue formation and local antibody production add to intra renal complement activation. Diagnosing lupus nephritis requires that the clinician has high index of suspicion in patients with known SLE and worsening renal function. Persistent eosinophilia can also occur in lupus nephritis. It is necessary for the patients with SLE to be routinely tested for early detection of any renal impairment.

Treatment of lupus nephritis aims to reduce symptoms, prevent disease progression, and maintain kidney function. There is no cure, but various treatments are used to achieve these goals. Medications like steroids (prednisone), immunosuppressive drugs (cyclophosphamide, mycophenolate mofetil), and monoclonal antibodies (rituximab, belimumab) are commonly prescribed. Additionally, supportive treatments such as diet changes, blood pressure medications (ACE inhibitors, ARBs), and diuretics are utilized to manage symptoms and protect kidney function.

"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 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.

Lupus Nephritis Emerging Drugs

QLG1074: Qilu Pharmaceutical

QLG1074 is an oral calcineurin inhibitor approved for the treatment of lupus nephritis (LN), a severe kidney inflammation caused by systemic lupus erythematosus (SLE). It works by suppressing the immune system and reducing the activity of T-cells, thereby lowering inflammation and protecting kidney function. When used alongside standard care, such as corticosteroids and mycophenolate mofetil, voclosporin has been shown to significantly improve renal response rates and reduce proteinuria in LN patients, offering a promising option for better disease management. The drug is currently in Phase III stage of its development for the treatment of lupus nephritis.

ADX-097: Q32 Bio

ADX-097 is based on a novel platform enabling tissue-targeted regulation of the complement system without long-term systemic blockade, a key differentiator from current complement therapeutics. Q32 Bio completed a first-in-human, Phase I ascending dose clinical study of ADX-097 in healthy volunteers. Results from the Phase I clinical trial demonstrated a favorable tolerability and immunogenicity profile across all single and multiple dose cohorts and weekly subcutaneous dosing met exposures for predicted complete complement inhibition in the tissue with no systemic inhibition. Currently, the drug is in the Phase II stage of its development for the treatment of Lupus Nephritis.

KYV-101: Kyverna Therapeutics

KYV-101 is an autologous version of a novel, fully human clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties well suited for use in B cell-driven autoimmune diseases such as lupus nephritis and other B-cell driven autoimmune diseases. It is currently in Phase I/II stage of development for the treatment of Lupus Nephritis.

CABA-201: Cabaletta Bio

CABA-201 is a fully human CD19 chimeric antigen receptor (CAR) T cell therapy containing a 4-1BB co-stimulatory domain. Cabaletta is advancing RESETTM (REstoring SElf-Tolerance) Phase I/II clinical trials in systemic lupus erythematous, myositis, systemic sclerosis and generalized myasthenia gravis, with potential application in a broad range of other autoimmune diseases. It is currently in Phase I/II stage of development for the treatment of Lupus Nephritis.

NKX019: Nkarta, Inc.

NKX019 is designed to target CD19-positive B cells, which play a significant role in the pathogenesis of autoimmune diseases like lupus. The therapy utilizes NK cells derived from healthy donors that are genetically modified to enhance their ability to eliminate these B cells. Notably, NKX019 is engineered to express a membrane-bound form of interleukin-15, which may improve the persistence and activity of the NK cells without the need for extensive cytokine support typically required in other therapies. It is currently in Phase I stage of development for the treatment of Lupus Nephritis.

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. 30+ 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, Qilu Pharmaceutical.

Phases

The report covers around 35+ 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 III, 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

• AstraZeneca
• Hoffmann-La Roche
• Qilu Pharmaceutical
• BeiGene
• RemeGen
• Argenx
• Jiangsu Lianhuan Pharmaceutical
• Novartis Pharmaceuticals
• Kyverna Therapeutics
• Cabaletta Bio
• Mono
• Century Therapeutics
• Yake Biotechnology
• Qyuns Therapeutics
• Resolve Therapeutics

Key Products

• Anifrolumab
• Obinutuzumab
• QLG1074
• Zanubrutinib
• Telitacicept
• Efgartigimod alfa
• RYSW01
• Iptacopan
• KYV-101
• CABA-201
• ANX009
• CNTY-101
• CD19/BCMA CAR T-cells
• QX002N
• RSLV-145

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