Products in Development

For many health conditions, products are constantly being developed to improve treatment. With multiple sclerosis (MS), many new products are being researched. These may provide improved treatment options for people with MS.^1,2

A big research area for MS is disease-modifying therapies (DMTs). These are also called disease-modifying drugs or DMDs. DMTs change the way a disease progresses. They also reduce MS attacks. There are many different types of DMTs being researched.^2,3

How does the development process work?

It can be challenging to bring a drug or product to market. In some cases, the research, development, and approval process can take 12 to 15 years. In the United States, the Food and Drug Administration (FDA) approves drugs to be safe for humans.²

There are 4 phases of drug approval. These 4 stages only start after animal studies and laboratory (lab) testing to prove that a drug is safe. Only about 1 out of 1000 drugs make it from lab testing to human testing. The 4 phases of drug approval involve trials in humans. These trials focus on how safe and effective the drug is. There are several different types of drugs in the development process for MS.²

Immunosuppressants and immunomodulators

Immunosuppressants and immunomodulators are some of the original MS drugs. They work by impacting the way that the immune system operates. This can be helpful in MS since the condition is caused by an overactive immune system. These are sometimes drugs that are already approved to treat cancer.^1,3

Examples of these drugs that are being studied for use in MS include laquinimod and cladribine. Ones that have recently been approved for MS include siponimod (Mayzent®) and ozanimod (Zeposia®).^1,3

Monoclonal antibodies

Monoclonal antibodies are a promising type of treatment for MS. They are a type of biologic. Monoclonal antibodies are proteins made in a lab. They are clones of antibodies in our bodies. Lab-made monoclonal antibodies help your immune system target specific cells. Examples of monoclonal antibodies already used or being researched for MS include:^3-5

• Ocrelizumab (Ocrevus®)
• Rituximab (Rituxan®)
• Ublituximab (Briumvi™)
• Ofatumumab (Kesimpta®)

Blood tests

Blood tests to track MS progression have been the focus of many studies. These tests allow doctors to measure key biomarkers to monitor MS symptoms and also evaluate a person's response to particular therapies. In turn, doctors can create personalized and more effective treatments.^6,7

While several studies on blood tests for MS are still underway, one blood test is already available in the United States. The Octave MS Disease Activity (MSDA) blood test analyzes levels of 18 key biomarkers that help doctors measure the level of new disease activity in people with MS.⁶

Vaccinations

Vaccinations are being studied as potential MS treatments. These are different from vaccines you might be used to. Vaccines typically work by teaching your body to have an immune reaction to a virus. Vaccines for MS are also called inverse vaccines. They work by tricking the immune system into not attacking myelin. Attacks on myelin are the cause of MS.⁸

Stem cell therapies

Stem cell therapy is a treatment that uses stem cells. Stem cells are special cells that can turn into many different specialized cells in the body. The use of stem cells for the treatment of MS is an up-and-coming research area. Different stem cell treatments are being researched. These might involve using stem cells to form new cells to make or repair myelin.^3,9

One type of stem cell therapy being used for MS is called KYV-101. KYV-101 is a type of chimeric antigen receptor T (CAR T) cell therapy that is used in treating people with treatment-resistant progressive MS who are not responding to other available treatments. It works by giving your immune system specially-trained T cells to fight against a protein that has been linked to MS.⁹

KYV-101 is currently in the testing phase, and the FDA has given it a "fast track" designation. This means that they recognize the potential importance of this treatment and are working to speed up its development and review process. The hope is that it could offer a new option for people with progressive forms of MS who have not found success with current treatments.⁹

Bone marrow transplant

Bone marrow transplants could use your own stem cells to fight MS. The goal behind this approach is to “reboot” an overactive immune system in MS. In this approach:^3,9

1. First, your healthy stem cells are taken.
2. Then your immune system is destroyed or reduced with drugs.
3. Once the immune cells are depleted, the stem cells are put back into your body.
4. The stem cells then help develop a new healthy immune system.

Much more research is needed to determine how safe and effective stem cell therapy and bone marrow transplants are for MS.^3,9

Combination treatments

Combination treatments involve more than one treatment. It is possible that two drugs could be better than one. But combination treatments and testing can be difficult. For example:^1,3

• Two drugs can interact in unexpected ways.
• Interactions might cause negative side effects and results.
• Interactions may cause the drugs’ effects to cancel each other out.
• It is hard to prove which treatment is working in a study.

More research is needed to confirm that combination treatments are effective for MS.^1,3

Clinical trials

Clinical trials play a crucial role in advancing research on treatments for MS. People who participate in MS clinical trials may receive experimental treatments. This allows researchers to test the safety and effectiveness of a new drug or therapy. There are many active clinical trials going on right now for MS.^10,11

Visit clinicaltrials.gov to view a list of the clinical trials that are currently active in the United States.