Multiple sclerosis - Pipeline Insight, 2024

This “Multiple sclerosis - Pipeline Insight, 2024,” report provides comprehensive insights about 100+ companies and 100+ pipeline drugs in Multiple sclerosis 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

Multiple sclerosis Understanding

Multiple sclerosis: Overview

Multiple sclerosis (MS) is a chronic disease affecting the central nervous system (the brain and spinal cord).MS occurs when the immune system attacks nerve fibers and myelin sheathing (a fatty substance which surrounds/insulates healthy nerve fibers) in the brain and spinal cord. This attack causes inflammation, which destroys nerve cell processes and myelin - altering electrical messages in the brain. MS is unpredictable and affects each patient differently - some individuals may be mildly affected, while others may lose their ability to write, speak or walk.

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

Multiple sclerosis Emerging Drugs Chapters

This segment of the Multiple sclerosis 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.

Multiple sclerosis Emerging Drugs

Ublituximab: TG TherapeuticsUblituximab (TG-1101) is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions (including antibody-dependent cellular cytotoxicity [ADCC] and complement dependent cytotoxicity [CDC]), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. In September 2021, TG Therapeutics announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, as a treatment for patients with relapsing forms of multiple sclerosis (RMS). The submission was based on the results of the ULTIMATE I & II trials, two identical Phase 3, randomized, global, multi-center, double-blinded, active-controlled trials evaluating ublituximab compared to teriflunomide in patients with RMS. The ULTIMATE I & II trials were conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

IMU-838: ImmunicVidofludimus calcium (IMU-838) is a small molecule investigational drug under development as an oral tablet formulation for the treatment of relapsing-remitting multiple sclerosis, or RRMS, inflammatory bowel disease, or IBD, and other chronic inflammatory and autoimmune diseases. On July 1, 2021, Immunic announced U.S. Food and Drug Administration, or FDA, clearance of its Investigational New Drug, or IND, application for the phase 3 ENSURE program of vidofludimus calcium in patients with RMS. The ENSURE program comprises two multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, is expected to enroll approximately 1,050 adult patients with active RMS at more than 100 sites in 14 countries, including the United States, Latin America, Central and Eastern Europe, and India. Patients will be randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks. Key secondary endpoints include volume of new T2-lesions, time to confirmed disability progression, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change, grey matter volume, and white matter volume. The ENSURE trials will be run concurrently. The first patient has been enrolled in November 2021.

ATA188: Atara BiotherapeuticsATA188, is an off-the-shelf, allogeneic EBV T-cell that utilizes a targeted antigen recognition technology that enables the T-Cells we administer to selectively identify cells expressing the EBV antigens that may be important in the pathophysiology of MS.

ANK-700: ANOKIONANK-700 is an investigational treatment for RRMS. It encompasses a previously identified myelin antigen that is implicated in driving Multiple Sclerosis. The antigen is delivered to the liver and immune system with the liver targeting glycosylation signature. The drug is currently in Phase I stage of clinical trila evaluation to treat multiple sclerosis.

Multiple sclerosis: Therapeutic Assessment

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

Major Players in Multiple sclerosis

There are approx. 100+ key companies which are developing the therapies for Multiple sclerosis. The companies which have their Multiple sclerosis drug candidates in the most advanced stage, i.e. preregistration include, TG Therapeutics.

Phases

This report covers around 100+ 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

Multiple sclerosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Parenteral
• intravenous
• Subcutaneous
• Topical.

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Product Type

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

Multiple sclerosis: Pipeline Development Activities

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

Multiple sclerosis Report Insights

• Multiple sclerosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• TG Therapeutics
• Immunic
• Atara Biotherapeutics
• ANOKION
• ImStem Biotechnology
• Merck Serono
• CinnaGen
• Immune Response BioPharma, Inc.
• Clene Nanomedicine
• GeNeuro SA
• Sanofi
• Bristol-Myers Squibb
• HuniLife Biotechnology, Inc.
• Emerald Health Pharmaceuticals
• Biogen
• RemeGen Co., Ltd.
• Antisense Therapeutics
• Immune Response BioPharma
• Biocad
• AB Science
• Genentech
• Novartis
• Pipeline Therapeutics
• ASLAN Pharmaceuticals
• GlaxoSmithKline
• Lucid Psycheceuticals
• Voronoi
• Hanmi Pharmaceutical
• Mapi Pharma
• f5 Therapeutics
• Autobahn Therapeutics
• AstraZeneca
• ZyVersa Therapeutics
• RedHill Biopharma
• Gossamer Bio
• Sarepta Therapeutics
• BrainStorm Cell Limited
• CytoDyn
• Pear Therapeutics
• ABION

Key Products

• Ublituximab
• IMU-838
• ATA188
• ANK-700
• IMS001
• Evobrutinib
• Ocrelizumab biosimilar
• VRN-04
• NeuroVax
• GSK 3888130B
• RB 104
• Belimumab
• ABN101
• ABX 002

Research programme: Autoimmune disorder therapeutics- Glatiramer acetate controlled release

• Leronlimab
• Pear-006
• GB7208
• IC 100-01
• Lucid MS
• CNM-Au8
• HM 15211
• Temelimab
• SAR441344
• ASLAN 003
• PIPE 858
• ATL 1102
• Ianalumab
• 11C-BMS-986196
• Fenebrutinib
• SAR 441344
• RC18
• BIIB061
• Masitinib
• BCD-132
• HuL001
• EHP-101
• IR 902

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