DelveInsight’s, “Multiple sclerosis Pipeline Insight, 2022,” report provides comprehensive insights about 100+ companies and 100+ pipeline drugs in the 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.
In the Multiple Sclerosis Pipeline Report, a detailed description of the drug is given which includes the mechanism of action of the drug, clinical studies, Multiple Sclerosis 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.
Key takeaways from the Multiple Sclerosis Pipeline Insight Report
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Recent Breakthroughs of Multiple Sclerosis Treatment Landscape
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.
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Multiple sclerosis Emerging Drugs Profile
Ublituximab: TG Therapeutics
Ublituximab (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.
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. 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 Biotherapeutics
ATA188, 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 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 Pipeline Therapeutics Assessment
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.
DelveInsight’s Multiple Sclerosis Pipeline reports covers around 100+ products under different phases of clinical development like
Scope of the Multiple Sclerosis Pipeline Report
Table of content
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