Bafiertam (Monomethyl Fumarate) for Multiple Sclerosis
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What is Bafiertam for MS?
Bafiertam (monomethyl fumarate) is an approved oral therapy for relapsing forms of multiple sclerosis (MS).
A disease-modifying therapy (DMT), it is designed to reduces the number of relapses, delays disability progression, and slows the development of new brain lesions in MS.
The treatment was developed by U.S.-based Banner Life Sciences.
Therapy Snapshot
| Brand Name: | Bafiertam |
| Chemical Name: | Monomethyl fumarate |
| Usage: | Disease-modifying therapy for relapsing forms of MS |
| Administration: | Oral capsules |
How does Bafiertam work?
MS is a neurodegenerative disease caused by the body’s immune system launching a misguided attack against healthy parts of the central nervous system — the brain, spinal cord, and optic nerves. These attacks lead to progressive nerve cell damage and death.
While the exact mechanism of action of Bafiertam is not fully known, the medication’s active ingredient, monomethyl fumarate (MMF), is broadly thought to reduce the inflammation that drives MS. It works by altering the activity of some immune cells.
This compound also leads to antioxidant activity that protects nerve cells from damage and prevents the migration of immune cells into the brain and spinal cord.
MMF also is the active ingredient in Tecfidera (dimethyl fumarate) and Vumerity (diroximel fumarate), two approved MS therapies marketed by Biogen. These medications work differently, however, delivering an inert precursor that is only converted into the active MMF molecule once inside the body.
Bafiertam delivers the similar amount of MMF as Tecfidera, but the compound in Tecfidera, dimethyl fumarate, is metabolically converted to MMF in the gastrointestinal tract. By delivering MMF directly, Bafiertam is expected to cause fewer and less severe gastrointestinal side effects than the older medication.
Who can take Bafiertam?
Bafiertam received tentative approval from the U.S. Food and Drug Administration (FDA) in 2018 for the treatment of adults with relapsing forms of MS.
It was only given final approval in April 2020, due to Biogen claiming the drug infringed on patents related to Tecfidera and launching litigation. Federal courts in the U.S. ruled that Bafiertam did not infringe on the patents, clearing the way for the therapy’s approval for patients with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
Who should not take Bafiertam?
Bafiertam is not recommended for people with a known allergy to MMF, dimethyl fumarate, diroximel fumarate, or any other ingredient in the medication. It also should not be given to those already taking Tecfidera, a generic formulation of Tecfidera, or Vumerity.
How is Bafiertam administered?
Bafiertam is available as soft gelatin, delayed-release capsules containing 95 mg of the active MMF molecule. The capsules are white and oval, printed with a “95” in black ink.
The recommended maintenance dose of the medication is 190 mg, taken as two oral capsules twice per day (four daily capsules in total).
During the first week of treatment, however, patients should receive only half a dose – 95 mg, or one capsule, twice daily. This so-called titration period may be skipped if patients were already receiving a fumarate therapy before starting on Bafiertam.
Bafiertam can be taken with or without food, but it is recommended that patients take the treatment without food if gastrointestinal side effects occur. Capsules must be swallowed whole, and not crushed, chewed, or sprinkled on food.
Taking aspirin 30 minutes before Bafiertam may lower the incidence of flushing, or reddening of the skin — a common side effect of the medication — but its use should be discussed with a healthcare provider.
| Administration | Oral capsules |
| Dosage | 190 mg, or two capsules; during titration period, 95 mg, or one capsule |
| Timing | Twice per day |
Bafiertam in clinical trials
Bafiertam’s approval was based primarily on data from two large Phase 3 clinical trials of Tecfidera: DEFINE (NCT00420212) and CONFIRM (NCT00451451).
These trials each enrolled more than 1,200 RRMS patients and showed that two years of dimethyl fumarate treatment significantly reduced relapse rates by about 50%, compared with a placebo. The number of new and enlarging brain lesions, and the mean number of lesions with brain inflammation, also were lowered by more than 70%.
The approval package also included data from Phase 1 studies demonstrating the bioequivalence and gastrointestinal safety of Bafiertam compared with Tecfidera in healthy volunteers. Biosimilars are medicines close in structure and function to approved biologic medications.
Bioequivalence Phase 1 trials
A Phase 1 trial (NCT04570670) enrolled 50 healthy individuals who were randomly assigned to receive a single dose of Bafiertam (190 mg) or Tecfidera (240 mg) in fasting conditions and were then given the other medication two days later.
Results established Bafiertam as a bioequivalent of Tecfidera, meaning the two medicines delivered the same amount of the active ingredient, at the same rate, and at the specific site of action. Bafiertam also was generally safe and well-tolerated.
The bioequivalence of Bafiertam (190 mg) and Vumerity (462 mg) was evaluated in another Phase 1 study (NCT05181215) involving 46 healthy participants. That trial is now complete, but results have not yet been disclosed.
Gastrointestinal Phase 1 trial
Banner sponsored a Phase 1 clinical trial (NCT04022473) in 2019 that investigated the gastrointestinal impact of Bafiertam versus Tecfidera. A total of 210 healthy adults were randomly assigned to receive one of the two medications for five weeks.
In the first week, participants adhered to the recommended titration scheme for each treatment, receiving either 95 mg of Bafiertam or 120 mg of Tecfidera twice daily. The maintenance doses were then administered over the next four weeks.
Results showed that the incidence and duration of gastrointestinal symptoms — including nausea, vomiting, diarrhea, flatulence, bloating, and constipation — over the full five weeks tended to be lower in the Bafiertam group. However, these differences failed to reach statistical significance.
Starting on week 3, however, the proportion of patients experiencing moderate to extreme gastrointestinal side effects was significantly lower with Bafiertam. The severity of specific symptoms such as diarrhea and vomiting also were significantly reduced.
Overall, fewer side effects were reported among individuals on Bafiertam.
Common side effects of Bafiertam
The most common side effects associated with Bafiertam, based on data from Tecfidera clinical trials, include:
- flushing
- abdominal pain
- diarrhea
- nausea
Liver Injury
Elevated levels of liver enzymes have been reported in patients, which generally resolved with treatment cessation. It is recommended that liver health be monitored when starting Bafiertam, and regularly during treatment.
Decreases in white blood cell counts
Bafiertam may cause low counts of lymphocytes, a type of infection-fighting immune cell. Blood tests should be performed at the treatment’s start, six months later, and again at regular intervals throughout treatment. If lymphocyte counts are persistently low, treatment continuation should be determined at the healthcare provider’s discretion relative to the specific patient.
Infections
Because it lowers the number of immune cells, Bafiertam may increase the risk of some severe infections, including those caused by herpes zoster, commonly known as shingles. In patients with serious active infections, it is recommended that treatment is withheld until the infection is resolved.
PML
Progressive multifocal leukoencephalopathy (PML) is a serious brain infection caused by the John Cunningham virus that also may occur in patients taking this therapy. At the first sign of PML, Bafiertam treatment should be discontinued.
Allergic Reactions
Some people may experience an allergic reaction to Bafiertam. Symptoms may include difficulty breathing, red or itchy welts, and swelling of the throat and tongue. If such a reaction occurs, treatment should be discontinued and patients should seek immediate medical care.
Pregnancy and breastfeeding
While adequate clinical data on the effects of Bafiertam in pregnancy do not exist, findings from animal models suggest that the medication may harm a developing fetus. Patients who become or wish to become pregnant while using this medication should discuss this issue with their healthcare provider.
It is not known whether Bafiertam can pass into breast milk. Those who plan to breastfeed while using this therapy also should talk with their healthcare team.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
FAQs about Bafiertam
Bafiertam received its final approval from the U.S. Food and Drug Administration in April 2020 for use in adults with relapsing forms of multiple sclerosis. It is indicated for clinically isolated syndrome, relapsing-remitting multiple sclerosis, and secondary progressive multiple sclerosis.
Animal studies suggest that Bafiertam may cause harm to a developing fetus. Patients who become or expect to become pregnant while on the medication should discuss their plans with a healthcare provider.
There are no alcohol or dietary restrictions for the medication, according to Banner Life Sciences, the company that developed Bafiertam. Nevertheless, people with a history of alcoholism have been excluded from clinical trials testing the therapy. Also, notably, patients taking Tecfidera and Vumerity, which are similar MS treatments, are advised not to drink alcohol at the same time as they take the medication. Since alcohol and Bafiertam can both cause can damage to the liver, patients should discuss with their healthcare provider whether it is safe to drink alcohol while on the therapy.
Because each patient will have a different disease experience, each person’s treatment response also will be unique. Patients are advised to speak with their healthcare providers about how Bafiertam may help in their case.
Weight gain and hair loss were not reported as side effects of Bafiertam in clinical trials. Some people who received Tecfidera, a medication with the same active ingredient, reported experiencing hair loss when using the treatment after its approval. Patients who experience these or other unexpected side effects should discuss them with their healthcare team.
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