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Neuromyelitis Optica Spectrum Disorder (NMOSD) - Pipeline Insight, 2021

  • ID: 4989083
  • Clinical Trials
  • July 2021
  • Region: Global
  • 108 Pages
  • DelveInsight

FEATURED COMPANIES

  • Abide Therapeutics
  • Bionure
  • Boston Pharmaceuticals
  • Harbour BioMed
  • NovelMed
  • RemeGen
This Neuromyelitis Optica Spectrum Disorder (NMOSD) - Pipeline Insight, 2021 provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Neuromyelitis Optica Spectrum Disorder (NMOSD) 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

Neuromyelitis Optica Spectrum Disorder (NMOSD) Understanding


Neuromyelitis Optica Spectrum Disorder (NMOSD): Overview


Neuromyelitis optica spectrum disorder (NMOSD), also known as Devic disease, is a chronic disorder of the brain and spinal cord dominated by inflammation of the optic nerve (optic neuritis) and the spinal cord (myelitis). The characteristic symptoms of NMOSD are either optic neuritis or myelitis, either of which may occur as the first symptom. Optic neuritis is an inflammation of the optic nerve leading to pain inside the eye which is rapidly followed by loss of clear vision (acuity). Usually, only one eye is affected (unilateral) although both eyes may be involved simultaneously (bilateral). Greater than 95% of patients with NMOSD report no relatives with the disease, but approximately 3% report having other relatives with the condition. There is a strong association with a personal or family history of autoimmunity, which are present in 50% of cases.

Neuromyelitis Optica Spectrum Disorder (NMOSD) - Pipeline Insight, 2021 report by the publisher outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Neuromyelitis Optica Spectrum Disorder (NMOSD) pipeline landscape is provided which includes the disease overview and Neuromyelitis Optica Spectrum Disorder (NMOSD) treatment guidelines. The assessment part of the report embraces, in depth Neuromyelitis Optica Spectrum Disorder (NMOSD) 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, Neuromyelitis Optica Spectrum Disorder (NMOSD) 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 Neuromyelitis Optica Spectrum Disorder (NMOSD) R&D. The therapies under development are focused on novel approaches to treat/improve Neuromyelitis Optica Spectrum Disorder (NMOSD).

Neuromyelitis Optica Spectrum Disorder (NMOSD) Emerging Drugs Chapters


This segment of the Neuromyelitis Optica Spectrum Disorder (NMOSD) 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.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Emerging Drugs


Telitacicept: RemeGen

Telitacicept is a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein designed to inhibit the development and survival of plasma cells and mature B cells, preventing the formation of autoantibodies. It works by binding to the cell-signaling molecules BLyS (B lymphocyte stimulator) and APRIL (a proliferation-inducing ligand). The drug is indicated for the treatment of systemic lupus erythematosus. The product is currently in Phase III stage of clinical trial evaluation for the treatment of neuromyelitis optica spectrum disorder.

Ravulizumab: Alexion Pharmaceuticals

Ravulizumab (ALXN 1210) is a humanized anti-C5 antibody, being developed by Alexion Pharmaceuticals. It binds to complement protein 5 (C5) and blocks its activation by complement pathway convertase, thus inhibiting the formation of the terminal complement complex. Specifically, inhibits cleavage of C5 into C5a and C5b. The drug is indicated for the treatment of hemolytic uraemic syndrome and paroxysmal nocturnal haemoglobinuria with the brand name Ultomiris. Ravulizumab is in Phase III clinical studies for acute lung injury, amyotrophic lateral sclerosis, COVID-19 pneumonia; myasthenia gravis, neuromyelitis optica, and thrombotic microangiopathies.

SHR1459: Reistone Biopharma

SHR1459 (TG 1701, EBI 1459) is an orally available, small molecule, covalently-bound Bruton's tyrosine kinase inhibitor. The drug is in Phase II clinical studies to treat neuromyelitis optical spectrum disorders.

BAT4406F: Bio-Thera Solutions

BAT4406F is an investigational ADCC-enhanced anti-CD20 mAb candidate in clinical development for the treatment of autoimmune diseases. BAT4406F is currently being evaluated in NMOSD, an orphan indication with an estimated prevalence of 0.5 to 10 per 100,000. BAT4406 is a type I glyco-engineered mAb that binds specifically to CD20 on B-cells, kills the B-cells by CDC, and enhances ADCC effect. B cells have been implicated in the pathogenesis of a number of autoimmune diseases, including the CNS disorders, multiple sclerosis (MS) and NMOSD. Depletion of B-cells could provide meaningful relief for these autoimmune diseases. The drug is being investigated in Phase I stage of development for the treatment of patients with NMOSD.

HBM9161: Harbour BioMed

HBM9161 is a fully human anti-FcRn monoclonal antibody which is being developed by Harbour BioMed. This molecule is currently in Phase I/II stage of clinical development for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD). FcRn plays a pivotal role in preventing the degradation of IgG antibodies. The physiologic function of FcRn is to modulate the catabolism of IgG antibodies, and inhibition of FcRn, such as through use of an FcRn targeting antibody, has been shown to reduce levels of pathogenic IgG antibodies. HBM9161 is a fully human monoclonal antibody targeting the FcRn receptor. Blocking the FcRn-IgG interaction may alleviate flare-ups in neuromyelitis optica spectrum disorder.

ARN-6039: Boston Pharmaceuticals

ARN-6039 is an oral and selective small molecule antagonist of retinoic acid-related orphan nuclear receptor gt (RORgt)/ RORg. RORgt is the key transcription factor and is the master regulator of human Th17 (T helper 17) cells, a unique subset of CD4+T cells. RORgt controls cellular differentiation, function and InterleukinIL-17 (IL-17 producing T-helper lymphocytes) release by Th17 cells and helps mediate the immunopathology of human autoimmune diseases such as Psoriasis (PsO), Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD), Colitis, Asthma, Multiple Sclerosis (MS) and Neuromyelitis Optica (NMO). BOS172767 has demonstrated preclinical proof-of-mechanism in both in vitro and in vivo preclinical models and is well tolerated in single ascending dose (SAD) studies in healthy volunteers (HV).

Neuromyelitis Optica Spectrum Disorder (NMOSD): Therapeutic Assessment


This segment of the report provides insights about the different Neuromyelitis Optica Spectrum Disorder (NMOSD) drugs segregated based on following parameters that define the scope of the report, such as:


Major Players in Neuromyelitis Optica Spectrum Disorder (NMOSD)


There are approx. 15+ key companies which are developing the therapies for Neuromyelitis Optica Spectrum Disorder (NMOSD). The companies which have their Neuromyelitis Optica Spectrum Disorder (NMOSD) drug candidates in the most advanced stage, i.e. phase III include, RemeGen.

Phases


This report covers around 15+ 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

Neuromyelitis Optica Spectrum Disorder (NMOSD) 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
  • Oral
  • Subcutaneous
  • Molecule Type

Products have been categorized under various Molecule types such as

  • Immunoglobulin
  • Monoclonal antibodies
  • Protein
  • Recombinant fusion proteins
  • Small molecules
  • Vaccine
  • Product Type

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

Neuromyelitis Optica Spectrum Disorder (NMOSD): Pipeline Development Activities


The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Neuromyelitis Optica Spectrum Disorder (NMOSD) 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 Neuromyelitis Optica Spectrum Disorder (NMOSD) drugs.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Report Insights

  • Neuromyelitis Optica Spectrum Disorder (NMOSD) Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Neuromyelitis Optica Spectrum Disorder (NMOSD) Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions Answered


Current Treatment Scenario and Emerging Therapies:

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

Key Players

  • RemeGen
  • Alexion Pharmaceuticals
  • Reistone Biopharma
  • Nihon Pharmaceutical
  • Harbour BioMed
  • Bio-Thera Solutions
  • Abide Therapeutics
  • Bionure
  • TG Therapeutics
  • ENDECE
  • Boston Pharmaceuticals
  • NovelMed

Key Products

  • Telitacicept
  • Ravulizumab
  • SHR1459
  • NPB-01
  • HBM9161
  • BAT4406F
  • ABX-1431
  • BN201
  • Ublituximab
  • NDC-1308
  • ARN-6039
  • NM8074
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Abide Therapeutics
  • Bionure
  • Boston Pharmaceuticals
  • Harbour BioMed
  • NovelMed
  • RemeGen

IntroductionExecutive Summary
Neuromyelitis Optica Spectrum Disorder (NMOSD): Overview
  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics
  • Comparative Analysis

Therapeutic Assessment
  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Late Stage Products (Phase III)
  • Comparative Analysis

Telitacicept: RemeGen
  • Product Description
  • Research and Development
  • Product Development Activities

Mid Stage Products (Phase II)
  • Comparative Analysis

SHR1459: Reistone Biopharma
  • Product Description
  • Research and Development
  • Product Development Activities

Early Stage Products (Phase I)
  • Comparative Analysis

BAT4406F: Bio-Thera Solutions
  • Product Description
  • Research and Development
  • Product Development Activities

Preclinical and Discovery Stage Products
  • Comparative Analysis

ARN-6039: Boston Pharmaceuticals
  • Product Description
  • Research and Development
  • Product Development Activities

Inactive Products
  • Comparative Analysis

Neuromyelitis Optica Spectrum Disorder (NMOSD) Key CompaniesNeuromyelitis Optica Spectrum Disorder (NMOSD) Key ProductsNeuromyelitis Optica Spectrum Disorder (NMOSD)- Unmet NeedsNeuromyelitis Optica Spectrum Disorder (NMOSD)- Market Drivers and BarriersNeuromyelitis Optica Spectrum Disorder (NMOSD)- Future Perspectives and ConclusionNeuromyelitis Optica Spectrum Disorder (NMOSD) Analyst ViewsNeuromyelitis Optica Spectrum Disorder (NMOSD) Key CompaniesAppendix
List of Tables
Table 1 Total Products for Neuromyelitis Optica Spectrum Disorder (NMOSD)
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 Neuromyelitis Optica Spectrum Disorder (NMOSD)
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
Note: Product cover images may vary from those shown

A selection of companies mentioned in this report includes:

  • RemeGen
  • Alexion Pharmaceuticals
  • Reistone Biopharma
  • Nihon Pharmaceutical
  • Harbour BioMed
  • Bio-Thera Solutions
  • Abide Therapeutics
  • Bionure
  • TG Therapeutics
  • ENDECE
  • Boston Pharmaceuticals
  • NovelMed
Note: Product cover images may vary from those shown