Tuesday, 03 August 2021 02:26 GMT

Recent Clinical Trials Analysis on Myasthenia Gravis Treatment


( MENAFN - GlobeNewsWire - Nasdaq Lo)s Angeles, USA, July 22, 2021 (GLOBE NEWSWIRE) -- Recent Clinical Trials Analysis on Myasthenia Gravis Treatment

Around 15+ key companies are developing the Myasthenia Gravis therapies. Argenx has its drug candidates in the Pre-registration stage. There is an increase in the number of clinical trials, which is expected to propel the treatment for Myasthenia Gravis. The emerging therapies presently comprise biologics and molecules with new mechanisms of action.

DelveInsight's“ Myasthenia Gravis Pipeline Insight ” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the Myasthenia Gravis pipeline landscapes. It comprises Myasthenia Gravis pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Myasthenia Gravis therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Myasthenia Gravis pipeline products.

Some of the key takeaways from the Myasthenia Gravis Pipeline Report

  • Major companies such as Argenx, Alexion Pharmaceuticals, RemeGen, Horizon Pharma, UCB Biopharma, DAS Therapeutics, AnTolRx, Cabaletta Bio, CytoDyn, NMD Pharma, Cartesian Therapeutics, Harbour BioMed, Kashiv Biosciences, Ahead Therapeutics, and others are developing potential drug candidates to improve the Myasthenia Gravis treatment scenario.
  • In March 2021, Argenx announced the FDA Acceptance of BLA Filing for Efgartigimod to treat Generalized Myasthenia Gravis.
  • Argenx is also on track to submit an application for efgartigimod to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in the first half of 2021 and the European Medicines Agency (EMA) in the second half of 2021.
  • In March 2021, Horizon Therapeutics announced the completion of the acquisition of Viela Bio, Inc.
  • Cabaletta Bio is developing MuSK-CAART that is designed to treat myasthenia gravis (MG), an autoimmune disease affecting the neuromuscular junction that can lead to motor impairment, muscle weakness, and respiratory failure.
  • DESCARTES-08 is the first CAR T-cell therapy for autoimmune disease. It is being developed by Cartesian Therapeutics to treat myasthenia gravis. Descartes-08 contains autologous CD8+ T-cells engineered with RNA chimeric antigen receptors (CARs) that bind B-cell maturation antigen (BCMA). BCMA is expressed ubiquitously by plasma cell clones that produce pathogenic autoantibodies. Descartes-08 binds and kills these cells, eliminating the autoantibody source.
  • RC18 is being investigated in Phase III clinical trial by RemGen . It is a novel first-in-class TACI-Fc fusion protein for the treatment of B-cell mediated autoimmune disease.

Get an overview of pipeline landscape @ Myasthenia Gravis Clinical Trials Analysis

Myasthenia Gravis is a chronic autoimmune neuromuscular disease that causes weakness in the skeletal muscles that exacerbates after periods of activity and improves after rest periods. 

Myasthenia Gravis Emerging Drugs

  • Efgartigimod: Argenx

Efgartigimod is an investigational antibody fragment designed to decrease disease-causing immunoglobulin G (IgG) antibodies and inhibit the IgG recycling process. Results from Phase III clinical trial (ADAPT) showed treatment with efgartigimod provided clinically meaningful improvements in strength and quality of life measures in generalized myasthenia gravis (gMG). Efgartigimod is under U.S. Food and Drug Administration (FDA) review with December 17, 2021, Prescription Drug User Fee Act (PDUFA) target action date

  • Inebilizumab: Horizon Therapeutics

Inebilizumab is a humanized, affinity-optimized, afucosylated IgG1 kappa (IgG1κ) monoclonal antibody (mAb) that binds to the B cell-specific surface antigen CD19. It is currently in the Phase III stage of development to treat Myasthenia Gravis and is being developed by Horizon Therapeutics (Viela Bio).

  • Ravulizumab: Alexion Pharmaceuticals

Ravulizumab is the first and only long-acting C5 complement inhibitor. The medication works by blocking the C5 protein in the terminal complement cascade, a part of the body's immune system. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its healthy cells. Alexion Pharmaceuticals reported positive topline results from a Phase III study evaluating the safety and efficacy of ravulizumab in adults with generalized myasthenia gravis (gMG). The company plans to make regulatory filings in the US, EU & Japan in late 2021 or early 2022, based on P-III results.

  • Inebilizumab: Horizon Therapeutics

Inebilizumab is a monoclonal antibody that binds to a protein called CD-19, found on the surface of immune B-cells. The therapy was designed to deplete these cells, which play a central role in the progression of autoimmune diseases like MG. In a $3.05 billion deal, Horizon Therapeutics acquired Viela Bio, the developer of inebilizumab, a potential treatment for autoimmune diseases such as myasthenia gravis. The therapy is currently being investigated in people with MG in Phase III clinical trial that is now recruiting participants in Columbia.

For further information, refer to the detailed report @ Myasthenia Gravis Pipeline Therapeutics

Scope of Myasthenia Gravis Pipeline Drug Insight

  • Coverage: Global
  • Major Players : 15+ Key Players
  • Prominent Players: Argenx, Alexion Pharmaceuticals, RemeGen, Horizon Pharma, UCB Biopharma, DAS Therapeutics, AnTolRx, Cabaletta Bio, CytoDyn, NMD Pharma, Cartesian Therapeutics, Harbour BioMed, Kashiv Biosciences, Ahead Therapeutics, and many others.
  • Key Drugs Profiles: 15+ Products
  • Phases:

· Myasthenia Gravis Therapies Late-stage (Phase III)
· Myasthenia Gravis Therapies Mid-stage (Phase II)
· Myasthenia Gravis Therapies Early-stage (Phase I) 
· Myasthenia Gravis Pre-clinical stage and Discovery candidates
· Discontinued and Inactive candidates 

  • Mechanism of Action:

· Complement C5 inhibitors
· Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
· Acetylcholinesterase inhibitors
· Immunologic cytotoxicity; T lymphocyte replacements
· Chloride channel antagonists
· CCR5 receptor antagonists
· Neonatal Fc receptor antagonists 

  • Molecule Types:

· Vaccines 
· Monoclonal Antibody
· Peptides
· Polymer
· Small molecule

  • Route of Administration:

· Infusion 
· Oral
· Subcutaneous 
· Intramuscular
· Intradermal
· Intranasal
· Parenteral
· Topical 

  • Product Types:

· Monotherapy
· Combination
· Mono/Combination 

Key Questions regarding Current Myasthenia Gravis Treatment Landscape and Emerging Therapies Answered in the Pipeline Report

  • What are the current options for Myasthenia Gravis treatment?
  • How many companies are developing therapies for the treatment of Myasthenia Gravis?
  • How many are Myasthenia Gravis emerging therapies in the early-stage, mid-stage, and late development stages to treat Myasthenia Gravis?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and significant licensing activities that will impact the Myasthenia Gravis market?
  • Which are the dormant and discontinued products and the reasons for the same?
  • What is the unmet need for current therapies for the treatment of Myasthenia Gravis?
  • What are the current novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing Myasthenia Gravis therapies?
  • What are the critical designations that have been granted for the emerging therapies for Myasthenia Gravis?
  • How many patents are granted and pending for the emerging therapies to treat Myasthenia Gravis?

Table of Contents

1 Myasthenia Gravis Report Introduction
2 Myasthenia Gravis Executive Summary
3 Myasthenia Gravis Overview
4 Myasthenia Gravis – DelveInsight's Analytical Perspective In-depth Commercial Assessment
5 Myasthenia Gravis Pipeline Therapeutics
6 Myasthenia Gravis Late Stage Products (Phase III)
6.1 Inebilizumab: Horizon pharma
7 Myasthenia Gravis Mid Stage Products (Phase II)
7.1 HBM9161: Harbour BioMed
8 Myasthenia Gravis Early Stage Products (Phase I/II)
8.1 Descartes-08: Cartesian Therapeutics
9 Myasthenia Gravis Pre-clinical and Discovery Stage Products
9.1 MuSK-CAART: Cabaletta Bio
10 Myasthenia Gravis Therapeutics Assessment
11 Myasthenia Gravis Inactive Products
12 Company-University Collaborations (Licensing/Partnering) Analysis
13 Myasthenia Gravis Key Companies
14 Myasthenia Gravis Key Products
15 Myasthenia Gravis Unmet Needs
16 Myasthenia Gravis Market Drivers and Barriers
17 Myasthenia Gravis Future Perspectives and Conclusion
18 Myasthenia Gravis Analyst Views
19 Appendix
20 About DelveInsight

Get a customized pipeline report @ Myasthenia Gravis Drugs Pipeline Report

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About DelveInsight
DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.


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