Multiple Sclerosis - Pipeline Insight, 2024

This “Multiple Sclerosis - Pipeline Insight, 2024” report provides comprehensive insights about 80+ companies and 85+ 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 of the central nervous system, characterized by the immune system attacking the myelin sheath, the protective covering of nerve fibers. This autoimmune response leads to inflammation and damage, disrupting communication between the brain and the rest of the body. The exact cause of MS is unknown, but it is believed to result from a combination of genetic predisposition and environmental factors such as viral infections, vitamin D deficiency, and smoking. MS typically manifests between the ages of 20 and 50 and is more prevalent in women.

There are several types of MS, with Relapsing-Remitting MS (RRMS) being the most common. RRMS is marked by episodes of new or worsening symptoms followed by periods of remission. Other forms include Secondary Progressive MS (SPMS), which evolves from RRMS and involves a steady progression of symptoms, and Primary Progressive MS (PPMS), which is characterized by a gradual worsening of symptoms from the onset without early relapses. Progressive-Relapsing MS (PRMS) is rare and involves steady progression combined with acute relapses.

Symptoms of MS are diverse and can range from mild to severe, affecting physical, cognitive, and emotional functions. Common symptoms include fatigue, difficulty walking, numbness or tingling, muscle weakness, vision problems, dizziness, bladder and bowel issues, cognitive difficulties, and mood changes. These symptoms can significantly impact daily life and vary widely among individuals, making MS a highly unpredictable disease.

Diagnosing MS involves a thorough medical history, neurological examinations, and various tests such as MRI scans to detect brain and spinal cord lesions, lumbar punctures to analyze cerebrospinal fluid, and evoked potential tests to measure electrical activity in the brain. Despite these tools, diagnosis can be challenging due to the variability of symptoms and the need to rule out other conditions.

While there is no cure for MS, treatment focuses on managing symptoms, reducing relapse frequency, and slowing disease progression. Disease-Modifying Therapies (DMTs) play a crucial role in altering the disease course, while symptomatic treatments and rehabilitation therapies help manage specific issues and maintain function. Lifestyle adjustments, including regular exercise, a healthy diet, and stress management, are also beneficial. With early diagnosis and effective management, many individuals with MS can lead active and fulfilling lives despite the challenges posed by the disease.

"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 III, II, II/III 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

IMU-838: Immunic

Vidofludimus 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 clinical study for the treatment of Multiple Sclerosis or ocular hypertension.

Masitinib: AB Science

Masitinib is a selective tyrosine kinase inhibitor, targeting innate immune cells (mast cells and microglia) that are involved in the pathophysiology of progressive multiple sclerosis (MS). The drug is an orally available small molecule designed to reduce the activity of certain cells of the innate immune system - the body’s first line of defense against foreign invaders - which have become increasingly implicated in the mechanisms underlying progressive MS. Masitinib’s safety and effectiveness were evaluated in a previous Phase IIb/III trial, called AB07002 (NCT01433497). It enrolled 611 patients with non-active SPMS or PPMS who were randomly assigned to receive one of two doses of masitinib (4.5 or 6 milligrams per kilogram per day) or a placebo twice daily for 96 weeks (about two years). Currently, the drug is in the Phase III stage of its development for the treatment of Multiple Sclerosis.

Foralumab: Tiziana Life Sciences

Foralumab is a fully human anti-CD3 monoclonal antibody (mAb). The company have recently completed Phase I clinical trials for progressive MS indication with nasal administration. Foralumab has demonstrated ability to activate regulatory T cells that systemically circulate to elicit targeted immunomodulation providing therapeutic benefit to patients. Currently, the drug is in the Phase II stage of its development for the treatment of Multiple sclerosis.

IMCY-0141: ImCyse

IMCY-0141 is the Company’s second clinical-stage compound. This Imotope™ is designed based on MOG (Myelin Oligodendrocyte Glycoprotein) with the aim to halt the progression of multiple sclerosis (MS) by stopping the body’s immune system from attacking the central nervous system and disrupting undesirable autoimmune responses that drive the destruction of the myelin sheath protecting the nerves. IMCY-0141 has shown promising results in several MS preclinical models, demonstrating an immune response that supports the proposed mode of action and inducing a memory response so that the treatment effect is long-lasting and requires less frequent dosing regimens. Also, if treatment is begun early enough, it has the potential to allow patients to live with minimal impact from the disease. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of multiple sclerosis.

BMS-986353: Bristol-Myers Squibb

BMS-986353, also known as CD19 NEX-T, is a chimeric antigen receptor (CAR) T-cell therapy developed by Bristol Myers Squibb. This therapy is being studied for its potential in treating various conditions, including severe, refractory autoimmune diseases like systemic lupus erythematosus (SLE) and multiple sclerosis. Clinical trials are ongoing to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 (BMS-986353) in participants with relapsing forms of multiple sclerosis or progressive forms of multiple sclerosis. Currently, the drug is in the Phase I stage of its development for the treatment of 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. 80+ 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. Phase III include, Immunic and AB Science.

Phases

DelveInsight’s report covers around 85+ 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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• 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

• ImCyse
• Lucid Psycheceuticals
• Immune Response BioPharma
• Guangzhou Lupeng Pharmaceutical
• Kyowa Kirin
• Nura Bio
• ImStem Biotechnology
• Hoffmann-La Roche
• Bristol-Myers Squibb
• Immunic
• AB Science
• Tiziana Life Sciences
• Clene Nanomedicine
• Supernus Pharmaceuticals
• InnoCare Pharma
• Oryzon Genomics
• GeNeuro SA
• AbbVie

Key Products

• IMCY-0141
• Lucid-MS
• NeuroVax
• LP-168
• KHK4827
• NB-4746
• CC-97540
• IMS-001
• RO7121932
• BMS-986196
• IMU-838
• Masitinib
• Foralumab
• CNM-Au8
• Botulinum toxin B
• Orelabrutinib
• Vafidemstat
• Temelimab
• Elezanumab

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