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Myasthenia Gravis Therapeutics Pipeline Analysis

Myasthenia Gravis Therapeutics Pipeline Analysis, 2017 - Clinical Trials & Results, Patent, Designation, Collaboration, and Other Developments

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Myasthenia gravis is a neuromuscular disease that leads to varying degrees of skeletal muscle weakness. It is an autoimmune disease resulting from the antibodies blocking or destroying nicotinic acetylcholine receptors at the junction between the nerve and muscle, thus preventing nerve impulses rom triggering muscle contractions. Growth is anticipated in the myasthenia gravis therapeutics pipeline on account of increasing participation of organizations, such as National Organization for Rare Disorder, that support research and development activities in field. The unbearable complications such as difficulty in vision, swallowing, weakness in upper arms and legs and impaired speech are also contributing to the growth of pipeline therapeutics of myasthenia gravis.

In August 2005, Debiopharm S.A. entered into a collaboration with DeveloGen AG for development of PTR-262, a novel peptide drug for the treatment of myasthenia gravis (MG). PTR-262 is derived from the myasthenogenic epitopes of the acetylcholine receptor (AChR) alpha-subunit, which specifically arrests the autoimmune destruction of AChR. Under the terms of the agreement, DeveloGen AG would receive milestone payments and, upon commercialisation of the product, royalties based on revenues of Debiopharm S.A., from worldwide sales. Debiopharm S.A. is an independent company, specialising in oncology, endocrinology and niche products, whereas, DeveloGen AG is a biopharmaceutical company, which mainly focuses on development of novel treatments for metabolic disorders. In March, 2016, Penn centre for innovation had developed therapeutic vaccine for myasthenia gravis. The advantages of vaccine are long lasting benefits, potentially permanent protection, prevention as well as reversal of chronic myasthenia gravis, potent safe and rapid acting.

In March 2015, Cytokinetics, Inc. published the results of Phase II clinical trial of tirasemtiv in generalized myasthenia gravis disorder. Tirasemtiv is the leading drug candidate from Cytokinetics' skeletal muscle contractility program and is being developed as a potential treatment for amyotrophic lateral sclerosis (ALS).

In April 2017, UCB Pharma, Ltd. started a Phase II randomized, investigator- and subject-blind, placebo-controlled, treatment sequence study evaluating the safety, tolerability, and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. This study is expected to be completed in September 2018. UCB7665 is also known as rozanolixizumab, which acts as immunomodulator. It is being used for treatment of thrombocytopenia and immunological disease. In September 2015, Novartis AG started a Phase II randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis. This trial is expected to be completed in December 2017. CFZ533 is a monoclonal antibody that blocks the action of CD40 ligands, which exist in some cells. In June 2015, Grifols Therapeutics Inc. started a Phase II clinical study to evaluate the efficacy and safety of lGIV-C as a corticosteroid sparing agent in corticosteroid dependent patients with generalized myasthenia gravis. The corticosteroid, which was used in the trial, IGIV-C, is an intravenous immunoglobulin. In March 2017, Bristol-Myers Squibb Company started Phase I clinical study of Orencia in myasthenia gravis patients inadequately responsive to conventional immunotherapy. Orencia is also known as abatacept, which is a soluble fusion protein that links the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1).

Some of the companies having a pipeline of myasthenia gravis therapeutics include UCB Pharma, Ltd. Novartis AG, Grifols Therapeutics Inc., Bristol-Myers Squibb Company, Catalyst Pharmaceuticals, Inc., DeveloGen AG, Debiopharm S.A.

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