Relapsing-Remitting Multiple Sclerosis - Pipeline Insight, 2024

This “Relapsing-Remitting Multiple Sclerosis - Pipeline Insight, 2024” report provides comprehensive insights about 25+ companies and 28+ pipeline drugs in Relapsing-Remitting 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

Relapsing-Remitting Multiple Sclerosis: Understanding

Relapsing-Remitting Multiple Sclerosis: Overview

The term multiple sclerosis refers to the distinctive areas of scar tissue (sclerosis - also called plaques or lesions) that result from the attack on myelin by the immune system. These plaques are visible using magnetic resonance imaging in the white and/or gray matter of people who have MS. Plaques can be as small as a pinhead or as large as a golf ball.

During Relapsing-Remitting Multiple Sclerosis (RRMS), inflammatory attacks on myelin and nerve fibers occur. Activated immune cells cause lesions in the CNS which generate symptoms of visual impairments, tingling and numbness, episodic bouts of fatigue, intestinal and urinary system disorders, spasticity, and learning and memory impairment. Nearly 65% of patients with RRMS will subsequently develop SPMS which is considered the second phase of this disease. Many individuals experience increased weakness, intestinal and urinary system disorders, fatigue, stiffness, mental disorders, and psychological impairment. The disease is rarely fatal, and most people with MS have a normal life expectancy.

The pathophysiology of MS is limited to the primary CNS. Two fundamental processes constitute general pathological process seen in MS patients: i) Focal inflammation resulting in macroscopic plaques and injury to the blood-brain barrier (BBB) ii) Neurodegeneration with microscopic injury involving different components of the CNS including axons, neurons, and synapse
Together, these two primary processes result in macroscopic and microscopic injury. Lesions referred to as plaques occur in waves throughout the disease course and result from focal inflammation. MS plaques predominantly center around small veins and venules and show sharp margins. Myelin loss, edema, and axonal injury are the chief components of plaque pathology. BBB disruption during active plaque inflammation corresponds to enhancement seen on MRI. Over time, the inflammatory process subsides, resulting in an astrocytic scar. Microscopically MS lesions show mononuclear infiltrate with perivenular cuffing and surrounding white matter infiltration. Monocytes and macrophages, which represent innate immunity, stimulate T-cell migration across the BBB. The overall net result is an injury to the BBB and the entry of systemic immune cells. Activation of microglia, the main antigen-presenting cells of the primary CNS, often precedes cell entry. CNS injury results in the initiation of cytotoxic activities of microglia with the release of nitrous oxide and other superoxide radicals.

Treatment of MS is challenging and involves several drugs acting via different mechanisms. The indication essentially depends on the clinical course and form of the disease. Although there is no proven therapy for the primary progressive form, several drugs are available to occasionally ameliorate the secondary progressive form and beneficially modify the activity of disease when dominated by the relapsing-remitting course. Treatment of MS has two aspects: disease-modifying therapy (DMT) for the underlying immune disorder, and therapies to relieve or modify symptoms. Disease-modifying agents are directed towards reducing the frequency of relapses and slowing progression. DMT has been approved for use only in relapsing forms of MS. Among patients with MS who switched DMTs, persistence was consistently low regardless of treatment. Although persistence with oral DMTs was slightly higher than with injectable DMTs, overall results indicate poor persistence to second-line therapy and highlight the need to improve long-term persistence with DMTs.

Interferon beta (IFN-beta) was first approved by the FDA for MS treatment on 1993. It has been shown to reduce relapse rate, decrease disability progression, and MRI evidence of disease activity. The clinical efficacy of IFN-beta is greater in RRMS than in SPMS. The exact of mechanism of how IFN-beta affects RRMS is uncertain, however several potential pathways have been postulated. New treatments can reduce long-term disability for many people with RRMS.

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

Relapsing-Remitting Multiple Sclerosis Emerging Drugs Chapters

This segment of the Relapsing-Remitting 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.

Relapsing-Remitting Multiple Sclerosis Emerging Drugs

IMU-838: Immunic AGVidofludimus 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. Bolstered by excellent clinical data from the phase II EMPhASIS trial, Immunic believed that vidofludimus calcium has the potential to demonstrate medically important advantages compared with other treatments, particularly for the early treatment of RMS patients, due to its placebo like safety profile and its robust anti-inflammatory and neuroprotective properties. Currently, the drug is in Phase III stage of its development for the treatment of RRMS.

Tolebrutinib: SanofiTolebrutinib is an investigational brain-penetrant Bruton’s tyrosine kinase inhibitor that achieves CSF concentrations needed for targeting B lymphocytes and microglial cells. Tolebrutinib is being evaluated in Phase III clinical trials for the treatment of relapsing forms of MS (RMS), non-relapsing secondary progressive MS (nrSPMS), and primary progressive MS (PPMS), and its safety and efficacy have not been evaluated by any regulatory authority worldwide.

Telitacicept: RemeGenTelitacicept (RC18) is a first-in-class TACI-Fc fusion protein for injection developed by RemeGen which targets two important cell-signaling molecules, B-cell lymphocyte stimulator (BLyS) and A proliferation inducing ligand (APRIL). Currently, the drug is in Phase II stage of its development for the treatment of RRMS.

ANK700: AnokionANK-700 is an investigational treatment for RRMS. It encompasses a previously identified myelin antigen that is implicated in driving Multiple Sclerosis. The drug deliver the antigen to the liver and immune system with the liver targeting glycosylation signature. In March 2021, Anokion SA announced the initiation of patient dosing in its Phase I clinical trial to evaluate ANK-700 for the treatment of people with relapsing remitting multiple sclerosis (RRMS).

Relapsing-Remitting Multiple Sclerosis: Therapeutic Assessment

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

Major Players in Relapsing-Remitting Multiple Sclerosis

• There are approx. 25+ key companies which are developing the therapies for Relapsing-Remitting Multiple Sclerosis. The companies which have their Relapsing-Remitting Multiple Sclerosis drug candidates in the most advanced stage, i.e. phase III include, Immunic.

Phases

This report covers around 28+ 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

Relapsing-Remitting 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

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

Relapsing-Remitting Multiple Sclerosis: Pipeline Development Activities

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

Relapsing-Remitting Multiple Sclerosis Report Insights

• Relapsing-Remitting Multiple Sclerosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Relapsing-Remitting 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 Relapsing-Remitting Multiple Sclerosis drugs?
• How many Relapsing-Remitting 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 Relapsing-Remitting Multiple Sclerosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Relapsing-Remitting 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 Relapsing-Remitting Multiple Sclerosis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Immunic AG
• Sanofi
• Anokion
• RemeGen
• HuniLife Biotechnology
• Biogen
• Clene Nanomedicine
• Novartis
• Celltrion
• Imcyse SA
• Takeda

Key Products

• IMU-838
• Tolebrutinib
• ANK700
• CNM Au 8
• Telitacicept
• HuL001
• BIIB-061
• Remibrutinib
• CT-P53
• IMCY-0141
• Ixazomib

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