IgA Nephropathy - Pipeline Insight, 2024

This “IgA Nephropathy- Pipeline Insight, 2024” report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in IgA Nephropathy 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

IgA Nephropathy: Understanding

IgA Nephropathy: Overview

IgA nephropathy (IgAN), or Berger’s disease, is the most common primary glomerular disease that can progress to end stage renal failure (ESRD). Because of the critical interaction between an intrinsic antigen (galactose-deficient IgA1) and circulating anti-glycan antibodies, IgA nephropathy can be considered an autoimmune disease. IgA is an antibody - a protein made by the immune system to protect the body from foreign substances such as bacteria or viruses. This condition most often occurs in Caucasian and Asian males. It usually appears when people are in their teens to late 30s but can occur at any age. Many cases resolve over time. However, in a subset of patients, the disease may not resolve and thus can lead to end-stage renal disease (ESRD) after 20-25 years. Rarely the condition can progress much more rapidly leading to renal failure within a few years, if not treated.

Patients can present with a range of symptoms, from haematuria or proteinuria to severe hypertension owing to renal damage. The severity of tubulointerstitial damage in IgAN correlates closely with the rate of renal function decline and long-term renal outcome. As immunochemical abnormality is not corrected by renal transplantation, IgAN can recur in patients after transplantation.

Multiple studies indicate that IgAN is an autoimmune disease but the primary cause of the disease is the systemic aberrant glycosylation of O­linked glycans (glycoproteins) in the hinge region of IgA1, which results in increased serum levels of galactose-deficient IgA1 (Gd­IgA1) that are recognized by glycan-specific IgA and IgG autoantibodies. As immunochemical abnormality is not corrected by renal transplantation, IgAN can recur in patients after transplantation. Metabolic factors such as dyslipidemia, obesity, hypertension (HT), and impaired fasting glucose have been reported to relate to onset and progression of chronic kidney disease (CKD) as IgAN is one of CKD.

Diagnosis relies on clinical and histological assessment. IgA Nephropathy (IgAN) can be diagnosed by renal biopsy and study of the kidney tissue using immunofluorescence microscopy. The pathology of IgAN is characterized by deposition (or possibly in situ formation) of pathogenetic polymeric IgA1 immune complexes (occasionally with IgG and IgM) in the glomer ular mesangium, proliferation of mesangial cells, increased synthesis of extracellular matrix and variable infiltration of macrophages, monocytes and T cells. The Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommend RASIs to reduce proteinuria in IgA patients with U-Prot>1 g/day. In IgAN patients with persistent proteinuria, corticosteroid therapy is recommended instead of conservative therapies. Combined corticosteroid therapy with RASIs was reported to reduce proteinuria and prevent progression to ESRD in several RCTs.

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

IgA Nephropathy Emerging Drugs Chapters

This segment of the IgA Nephropathy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III 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.

IgA Nephropathy Emerging Drugs

• Atrasentan: Chinook Therapeutics

Atrasentan is a potent and selective inhibitor of the endothelin A receptor (ETA) that has the potential to provide benefit in multiple chronic kidney diseases by reducing proteinuria and having direct anti-inflammatory and anti-fibrotic effects to preserve kidney function. Chinook selected IgAN as the lead indication for atrasentan due to the role of ETA activation in driving proteinuria, mesangial cell activation, kidney inflammation and fibrosis, the hallmarks of IgAN disease progression. Currently, the drug is in Phase III stage of Clinical trial evaluation for the treatment of IgA Nephropathy.

• SHR-2010: Guangdong Hengrui Pharmaceutical Co., Ltd.

SHR-2010 is a drug being studied for the treatment of Primary IgA Nephropathy. It is an injection developed by Guangdong Hengrui Pharmaceutical Co., Ltd., currently in Phase II of research. The drug is aimed at inhibiting MASP2protein. Clinical trials are ongoing to evaluate the efficacy, safety, and pharmacokinetics of SHR-2010 in patients with
Primary IgA Nephropathy.

• TAK-079: Takeda

TAK-079, also known as mezagitamab, targets CD38-expressing cells, including plasmablasts, plasma cells, and natural killer cells, leading to their depletion. The rationale for using TAK-079 in IgA nephropathy is that by reducing plasma cells responsible for producing the abnormal IgA1 protein, it may help prevent the formation of pathogenic immune complexes and subsequent kidney injury. In a Phase 1b clinical trial, TAK-079 is being evaluated for safety, tolerability, pharmacokinetics, and efficacy in patients with primary IgA nephropathy who are receiving stable background therapy.

IgA Nephropathy: Therapeutic Assessment

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

Major Players in IgA Nephropathy

There are approx. 25+ key companies which are developing the therapies for IgA Nephropathy. The companies which have their IgA Nephropathy drug candidates in the most advanced stage, i.e. Phase III include, Chinook Therapeutics.

Phases

This report covers around 30+ 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

IgA Nephropathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

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

IgA Nephropathy: Pipeline Development Activities

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

IgA Nephropathy Report Insights

• IgA Nephropathy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Chinook Therapeutics
• Guangdong Hengrui Pharmaceutical Co., Ltd.
• Takeda
• Visterra
• Novartis Pharmaceuticals
• Wuhan Createrna Science and Technology
• Jiangsu HengRui Medicine Co., Ltd.
• Takeda
• Selecta Biosciences
• Shanghai Alebund Pharmaceuticals

Key Products

• Atrasentan
• SHR-2010
• TAK-079
• Sibeprenlimab
• LNP023
• MY008
• HR19042
• Mezagitamab
• Research programme: IgA proteases
• AP 305

This product will be delivered within 1-3 business days.