Neuromyelitis Optica Spectrum Disorder (NMOSD) - Pipeline Insight, 2024

This “Neuromyelitis Optica Spectrum Disorder (NMOSD) - Pipeline Insight, 2024,” report 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, 2024 report 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 spectrumdisorder.

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 spectrumdisorders.

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 withNMOSD.

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 spectrumdisorder.

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 Interleukin IL-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

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

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

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