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Biogen has pioneered the development of multiple sclerosis (MS) treatments for more than 25 years. We continue to innovate to advance MS treatment and improve outcomes for patients. Our research is focused on potentially transformative therapies, including the potential repair of the damage caused by MS. Our ongoing research into neurodegeneration and nerve repair will help pioneer new therapeutic solutions that may bring us closer to a cure for MS.
At the same time, we are working with leading academic institutions and MS treatment centers to advance better ways to diagnose, monitor and manage MS. We are also driving advances toward precision medicine by using new technologies to develop innovative programs and tools to better understand, measure and manage the treatment of MS. Together with our partners, we are working to enable doctors and patients to make more evidence-based, individualized treatment decisions with the goal of improving MS care.
Our innovative research collaborations merge technologies like biomarkers and wearable sensors with real-world data from routine care to generate standardized, high-quality data that may help drive personalized treatment.
We developed one of the world’s largest MS databases to investigate critical questions about this disease, including if there are potential predictors of MS progression, or if certain treatments used early enough may have potential long-term benefits for patients, such as delaying the need for walking aids and wheelchairs or slowing the deterioration of other critical functions.
The work we are doing today in MS is designed to expand our focus well-beyond treatment and is vital to helping us better understand this disease.
Therapies
Today, our industry-leading portfolio of medicines helps address the diverse needs people living with MS may have throughout their lives.
We have the most robust portfolio of MS therapies in the industry with four disease-modifying therapies and one symptomatic therapy; globally, more than one in three MS patients is currently treated with a Biogen product.
We are always working to further our understanding of MS and how to treat it. This includes applying human genetics to understand the basis of disease progression, investigating new approaches to repair damaged nerves in the central nervous system with the goal of improving pre-existing disability, and looking at ways of treating progressive forms of MS.
Below you’ll find our current investigational therapies in MS.
Investigational candidates in multiple sclerosis
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BIIB098 (diroximel fumarate; DRF)
Multiple sclerosis (MS)
Licensed from Alkermes.
MS causes the body’s immune system to attack myelin, a protective sheath covering nerve fibers. Damage to myelin “short circuits” communication between the brain, spinal cord and other areas of the body, severely impairing such neurological functions as mobility, vision and thinking. Over time, the nerves themselves can become damaged permanently.
How this investigational therapy could help:
Diroximel fumarate (DRF) is an investigational, next-generation, oral fumarate for the treatment of MS and is differentiated from the currently marketed TECFIDERA (dimethyl fumarate) based on its chemical structure. Upon oral administration, DRF is rapidly converted to its active metabolite monomethyl fumarate (MMF). If approved, DRF may potentially offer differentiated gastrointestinal tolerability profile and offer patients with relapsing forms of MS another treatment choice.
BIIB074 (vixotrigine)
Small fiber neuropathy (SFN)
Small fiber neuropathy (SFN) is a condition characterized by severe pain attacks that typically begin in the feet or hands. Patients may experience spontaneous burning, itching or shooting pain which may be triggered by stimuli that are ordinarily not painful, such as hot or cold temperatures or light touch. SFN is a neuropathic pain condition which can have different causes, such as diabetes or vitamin B12 deficiency, or the cause may be unknown.
How this investigational therapy could help:
Vixotrigine is a state- and use-dependent, Nav1.7 channel blocker that also inhibits other voltage-gated sodium channels. It is a centrally and peripherally acting small molecule.
This disease causes the body’s immune system to attack myelin, a protective sheath covering nerve fibers. Damage to myelin “short circuits” communication between the brain, spinal cord and other areas of the body, severely impairing such neurological functions as mobility, vision and thinking. Over time, the nerves themselves can become damaged permanently.
How this investigational therapy could help:
LINGO-1 is a CNS specific-protein that is involved in the development of myelin. In patients with MS, LINGO-1 may inhibit myelin growth when it binds with its receptor. Data suggest that the antibody anti-LINGO-1 could block this process, potentially allowing for the re-myelination and restoration of nerve communication in MS patients.
TMS-007 (plasminogen modulator)
Stroke
*Option to acquire from TMS Co., Ltd.
It is estimated that nearly two million people in the United States and the European Union will have a stroke each year. Stroke is a leading cause of mortality and serious long-term disability. There is a substantial unmet medical need for new therapies that can improve outcomes in acute stroke.
How this investigational therapy could help:
TMS-007 is a plasminogen activator with a novel mechanism of action associated with breaking down blood clots and is believed to inhibit local inflammation at the site of thrombosis. This unique combination could position TMS-007 as a best in class thrombolytic for individuals with acute ischemic stroke (AIS) with potential for an extended treatment window as compared to current thrombolytic agents.
TMS-007 is a small molecule which has previously demonstrated an acceptable safety profile in a Phase 1 study and has also reduced infarct volume (area of dead tissue resulting from failure of blood supply) in experimental, preclinical, embolic and thrombotic stroke models.
TMS-007 is currently being evaluated in a double-blind, placebo-controlled Phase 2 study in Japan, designed to investigate the safety and efficacy of a single IV administration of TMS-007 in approximately 90 patients with AIS up to 12 hours after stroke onset. The Phase 2 study initiated with the first patient dosed in February 2018.
BIIB110 (myostatin pathway inhibitor)
Spinal muscular atrophy (SMA)
Acquired from AliveGen, Inc.
SMA is a genetic, progressive and often terminal rare disease that affects an individual’s ability to walk, eat and, ultimately, breathe. Debilitating and often fatal, SMA affects approximately one in 10,000 live births and is a leading genetic cause of death among infants.
How this investigational therapy could help:
Inhibition of the myostatin pathway is a genetically validated target for muscle enhancement. BIIB110 is a hybrid activin II receptor (ACTIIR) ligand trap that sequesters both myostatin and activins while sparing the related ligand bone morphogen protein 9 (BMP9). This targeted mechanism of action may result in greater muscle mass, function and improved safety compared to other myostatin inhibition approaches.
Biogen conducts clinical trials in MS related to the investigational therapies in our pipeline to evaluate the efficacy and safety as potential medicines.
Deciding to participate in a clinical trial requires careful consideration. In most cases, the therapies investigated in clinical trials are not yet approved by regulatory agencies like the U.S. Food and Drug Administration (FDA). The benefits and risks of taking the treatment are not completely known. By volunteering for a clinical trial, you are helping the medical community determine whether new treatments are safe and effective.
As part of our ongoing commitment to people living with MS, Biogen provides extra support through the Above MS™ program.
There are many benefits to joining the Above MS program. Members will get extra help from those who understand MS, including:
Specially tailored information from people who are living with relapsing MS, but are also experts in areas such as financial planning, cooking, exercise, and many other areas
One-on-one MS support over the phone
A community of peers
Information about Biogen treatment options and support services
Please keep in mind that a doctor is always the primary resource when it comes to MS and treatment.
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