The main goal of current drugs for MS is to reduce the autoimmune reaction against CNS components, mainly myelin. These drugs act to suppress lymphocyte subsets, reduce trafficking of immune cells across the blood-brain-barrier, and/or to cause autoreactive cells to be retained in peripheral lymphoid organs.
While some may delay disease progression, there is scant evidence that any of them reverses neurological decline that occurs in all forms of MS due primarily to chronic demyelination. The hope is that BIIB033 will be the first therapy to promote recovery of injured axons in MS, and that remyelination might improve or resolve the functional disability characteristic of MS.
Other potential remyelination therapies in development are:
- GSK239512 (Glaxo SmithKline) – an oral, histamine 3 receptor antagonist
- rHIgM22 (Acorda Therapeutics) – a naturally occurring antibody that promotes myelin repair
- VX15/2503 (Vaccinex) – an anti- Semaphorin 4D
- The Pathobiology of MS
- Current treatments for RRMS
- Remyelination as a Therapeutic Approach in MS
- LINGO-1 blockade in animals promotes remyelination
- Preclinical Experiments
- Clinical trials
- Ongoing Phase II Trials
Clinical And Regulatory Discussion
- How relevant are animal models to human MS disease?
- How can clinical benefit of BIIB033 in MS be demonstrated?
- Are BIIB033 levels in the CNS after systemic administration sufficient to produce remyelination in humans?
- What are relevant and acceptable clinical endpoints?
- Imaging techniques to assess remyelination still need to be validated
- What biomarkers may be useful to suggest remyelination benefit?
- What possible scenarios could play out for clinical development of BIIB033?
- Competitive Landscape
Overview of the Market for MS Therapies
- US Market for MS Therapies
- What price can BIIB033 command?
- Who will be candidates for BIIB033?
- LINGO-1 could be a therapeutic target in other conditions besides MS