Autoimmune Hepatitis - Pipeline Insight, 2024

This “Autoimmune Hepatitis - Pipeline Insight, 2024” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Autoimmune Hepatitis 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

Autoimmune Hepatitis: Understanding

Autoimmune Hepatitis: Overview

Autoimmune hepatitis is a condition where the liver undergoes long-term inflammation, but the exact cause is uncertain. It's believed to stem from a combination of genetic predisposition, environmental factors, and immune system malfunction. This leads to ongoing inflammation of liver cells and eventual scarring of the liver tissue. There are two main types: Type 1, characterized by anti-smooth muscle antibodies (ASMA) possibly accompanied by anti-nuclear antibodies (ANA), and Type 2, marked by the presence of anti-liver/anti-kidney microsome (anti-LMK) type 1 antibodies or anti-liver cytosol (anti-LC) type 1 antibodies.

Autoimmune hepatitis is characterized by hypergammaglobulinemia, circulating autoantibodies, and interface hepatitis on liver histology, with a favorable response to immunosuppression. The histological features include a chronic hepatitis pattern with mild to moderate lymphocytic inflammation in the portal tracts, rich in plasma cells, and interface activity, along with intact native bile ducts and minimal lobular inflammation. Trichrome staining typically reveals no significant increase in fibrosis. A liver biopsy is crucial for diagnosis, as the histologic findings differentiate AIH from other liver conditions, although correlation with clinical and laboratory data is necessary due to potential overlap with viral hepatitis or drug-induced liver injury.

Autoimmune hepatitis can manifest with a variety of signs and symptoms, ranging from mild to severe. Common symptoms include fatigue, abdominal discomfort or pain, jaundice, dark urine, pale stools, loss of appetite, nausea, and unintended weight loss. Some individuals may experience joint pain, itching, and skin rashes. In severe cases, autoimmune hepatitis can lead to complications such as cirrhosis, which can cause additional symptoms like fluid retention in the abdomen (ascites), confusion, easy bruising or bleeding, and swelling in the legs.

Treatment for autoimmune hepatitis involve initiating therapy in patients meeting specific criteria, including significantly elevated liver enzymes, high gamma globulin levels, and specific histological findings on liver biopsy. Corticosteroids, particularly prednisone, are the mainstay of treatment, either as monotherapy or in combination with azathioprine, although budesonide may be used as an alternative to reduce side effects. Remission is achieved when symptoms resolve, inflammatory markers normalize, and liver histology improves. Regular monitoring is essential, as relapse can occur after discontinuing therapy, necessitating ongoing management to prevent cirrhosis development and monitor for hepatocellular carcinoma. Liver transplantation is considered for patients with fulminant hepatic failure or disease progression despite treatment.

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

Autoimmune Hepatitis Emerging Drugs Chapters

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

Autoimmune Hepatitis Emerging Drugs

VAY736: Novartis

VAY736 is an antibody that targets B-cell activating factor receptor (BAFF-R), designed to block BAFF-R-mediated signaling and to deplete B-cells through antibody-dependent cellular cytotoxicity. The drug is currently being evaluated under Phase II/III clinical trial for the treatment of patients with Autoimmune Hepatitis.

JKB-122: TaiwanJ Pharmaceuticals

JKB-122 is a small molecule and long-acting TLR4 antagonist currently under development by TaiwanJ Pharmaceuticals for the treatment of autoimmune hepatitis (AIH), non-alcoholic steatohepatitis (NASH), and chronic liver disease (CLD). It has demonstrated anti-fibrotic, immuno-modulating, and anti-inflammatory activities in preclinical models, as well as improvement of liver injuries by hepatoprotectant property. Several clinical trials have been conducted or are ongoing to evaluate the efficacy and safety of JKB-122 in AIH patients, with positive results reported from a Phase II trial showing improvement on targeted objectives and relevant biomarkers after 24 weeks of treatment.

Autoimmune Hepatitis: Therapeutic Assessment

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

Major Players in Autoimmune Hepatitis

There are approx. 10+ key companies which are developing the therapies for Autoimmune Hepatitis. The companies which have their Autoimmune Hepatitis drug candidates in the most advanced stage, i.e. Phase II/III include, Novartis.

Phases

DelveInsight’s report covers around 10+ 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

Autoimmune Hepatitis 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.

Autoimmune Hepatitis: Pipeline Development Activities

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

Autoimmune Hepatitis Report Insights

• Autoimmune Hepatitis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Novartis
• Taiwan Pharmaceuticals
• Kezar Life Sciences

Key Products

• VAY736
• JKB-122
• Zetomipzomib

Please note: The report will be dispatched within 2-3 days