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Myasthenia Gravis - Pipeline Insight, 2024

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    Clinical Trials

  • 80 Pages
  • June 2024
  • Region: Global
  • DelveInsight
  • ID: 4036825
This “Myasthenia Gravis- Pipeline Insight, 2024” report provides comprehensive insights about 20+ companies and 21+ pipeline drugs in Myasthenia Gravis 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

Myasthenia Gravis: Understanding

Myasthenia Gravis: Overview

Myasthenia gravis (MG) is the most common disorder affecting the neuromuscular junction (NMJ) of the skeletal muscles. It usually involves muscles of the eyes, throat, and extremities. The reduced transmission of electrical impulses across the neuromuscular junction due to the formation of autoantibodies against the specific postsynaptic membrane proteins consequently causes muscle weakness. Myasthenia gravis causes a significant number of complications. These include myasthenic crisis, an acute respiratory paralysis that requires intensive care, as well as adverse events due to long term medication treatment like opportunistic infections and lymphoproliferative malignancies.

Myasthenia gravis has a prevalence of 20 per 100,000 population in the US. It exhibits a female predominance in those less than 40 years of age and a male predominance in those greater than 50 years of age. Childhood MG is quite uncommon in the western populations but is prevalent in Asian countries, with the involvement of around 50% of patients aged less than 15 years.

The mainstay of myasthenia gravis (MG) treatment involves cholinesterase enzyme inhibitors and immunosuppressive agents. Symptomatic treatment with acetylcholinesterase inhibitors like pyridostigmine increases ACh levels at the neuromuscular junction. Immunotherapy includes glucocorticoids, azathioprine, and second-line agents like cyclosporine. Monoclonal antibodies such as rituximab and eculizumab are used for drug-resistant cases. Intravenous immunoglobulins (IVIG) and plasmapheresis are crucial for myasthenic crisis. Thymectomy is indicated for specific subtypes of MG, excluding MuSK MG and non-thymomatous ocular MG without generalization.

The complication of myasthenia gravis includes myasthenic crisis, usually secondary to infections, stress, or acute illnesses.

Treatment complications include long term steroid effects like osteoporosis, hyperglycemia, cataracts, weight gain, hypertension, and avascular necrosis of the hip. There is also the risk of lymphoproliferative malignancies, as well as opportunistic infections such as systemic fungal infections, tuberculosis, and Pneumocystis carinii pneumonia with chronic immunosuppressive therapy. Symptoms include cramps, lacrimation, increased salivation, muscular weakness, muscular fasciculation, paralysis, diarrhea, and blurry vision.

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

Myasthenia Gravis Emerging Drugs Chapters

This segment of the Myasthenia Gravis 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.

Myasthenia Gravis Emerging Drugs

  • Telitacicept: RemeGen
Telitacicept is an antibody fusion protein, which can inhibit overexpression of two cell factors, namely recombinant B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), simultaneously and inhibit B cells proliferation and maturation. A total of eight of its indications in the field of autoimmune diseases are in commercialization or late-stage clinical trials. The drug is currently being evaluated under Phase III clinical trials for the treatment of myasthenia gravis.
  • KYV-101: Kyverna Therapeutics
KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. Kyverna is currently conducting trials of KYV-101 in patients with lupus nephritis, systemic sclerosis, and myasthenia gravis are in preparation. The drug is currently being evaluated under Phase II clinical trial for the treatment of myasthenia gravis.
  • 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 RESET (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.

Myasthenia Gravis: Therapeutic Assessment

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

Major Players in Myasthenia Gravis

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

Phases

This report covers around 21+ 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

Myasthenia Gravis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
  • Intra-articular
  • Intraocular
  • Intrathecal
  • Intravenous
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal
  • Molecule Type

Products have been categorized under various Molecule types such as

  • Oligonucleotide
  • Peptide
  • Small molecule
  • Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Myasthenia Gravis: Pipeline Development Activities

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

Myasthenia Gravis Report Insights

  • Myasthenia Gravis Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

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

Key Players

  • RemeGen
  • Takeda
  • Immunovant Sciences
  • Alexion Pharmaceuticals
  • Regeneron Pharmaceuticals
  • Cabaletta Bio
  • Momenta Pharmaceuticals
  • Kyverna Therapeutics
  • Amgen
  • COUR Pharmaceutical Development Company

Key Products

  • Telitacicept
  • TAK-079
  • RVT-1401
  • Ravulizumab
  • Pozelimab
  • MuSK-CAART
  • M281
  • KYV-101
  • Inebilizumab
  • CNP-106


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Table of Contents

IntroductionExecutive Summary
Myasthenia Gravis : Overview
  • Introduction
  • Etiology
  • Treatment and Management
  • Clinical Complications
Pipeline Therapeutics
  • Comparative Analysis
Therapeutic Assessment
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type
  • Assessment by Product Type
  • Assessment by Stage and Product Type
Myasthenia Gravis - Analytical Perspective
Late Stage Products (Phase III)
  • Comparative Analysis
Telitacicept: RemeGen
  • Product Description
  • Research and Development
  • Product Development Activities
Mid Stage Products (Phase II)
  • Comparative Analysis
KYV-101: Kyverna Therapeutics
  • Product Description
  • Research and Development
  • Product Development Activities
Early Stage Products (Phase I)
  • Comparative Analysis
Drug name: Company name
  • Product Description
  • Research and Development
  • Product Development Activities
Preclinical and Discovery Stage Products
  • Comparative Analysis
Drug name: Company name
  • Product Description
  • Research and Development
  • Product Development Activities
Inactive Products
  • Comparative Analysis
Myasthenia Gravis- Collaborations Assessment- Licensing / Partnering / FundingMyasthenia Gravis- Unmet NeedsMyasthenia Gravis- Market Drivers and BarriersAppendix
List of Tables
Table 1 Total Products for Myasthenia Gravis
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products
List of Figures
Figure 1 Total Products for Myasthenia Gravis
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • RemeGen
  • Takeda
  • Immunovant Sciences
  • Alexion Pharmaceuticals
  • Regeneron Pharmaceuticals
  • Cabaletta Bio
  • Momenta Pharmaceuticals
  • Kyverna Therapeutics
  • Amgen
  • COUR Pharmaceutical Development Company