New Data Available from Phase 3 Trial on Zeposia for Multiple Sclerosis

In early March 2024, Clinical Trials Arena reports that global biopharmaceutical company Bristol Myers Squibb shared new data from the Phase 3 DAYBREAK study. Within the study, researchers explored how safe and effective oral Zeposia (ozanimod) is for relapsing multiple sclerosis. The National Multiple Sclerosis Society describes Zeposia as:

a sphingosine 1-phosphate receptor module, which is thought to act by retaining certain white blood cells (lymphocytes) in the lymph nodes, thereby preventing those cells from crossing the blood-brain barrier into the central nervous system (CNS). Preventing the entry of these cells into the CNS reduces inflammatory damage to nerve cells.

Five years of trial data show that Zeposia is very safe for use in multiple sclerosis. Further, it is effective, with an annual relapse rate of just 0.098. For those who discontinued treatment, 2.2% had a relapse by three months after discontinuation.

A majority of participants also did not see their disease progress by six months. Although safe and generally well-tolerated, 89% of people in the study had adverse reactions, most commonly headaches, the common cold, upper respiratory tract infection, and COVID-19.

What to Know About Multiple Sclerosis (MS)

Multiple sclerosis is a chronic central nervous system (CNS) disease. While the exact cause of MS is unknown, multiple sclerosis is considered an autoimmune disease. Essentially, the immune system mistakenly attacks the myelin sheath (the protective covering of nerve cells). As the myelin sheath and nerve cells become damaged, signals to and from the brain are disrupted. Multiple sclerosis can be progressive (with no remission) or relapsing/remitting (periods of symptoms interspersed with periods of remission).

An estimated 2.3 million people worldwide, and 400,000 people in the United States, have multiple sclerosis. However, given the prevalence of misdiagnosis or lack of diagnosis, the population size might be even greater. Multiple sclerosis most often manifests between ages 20 and 40, although it is commonly seen throughout the wide age spectrum of 15 to 60 years old. Like many autoimmune conditions, MS is more common in females, with females being 2x more likely than males to develop this disease.

Symptoms of MS can include double/blurred visionoptic neuritisdifficulty walkingparesthesia (abnormal feelings of pain, numbness, prickling, or pins/needles), red-green color distortionmuscle weakness in the arms and legs, depression, bowel and bladder issuesspeech difficulties, fatiguemuscle spasticitypoor coordinationtremordizziness, and hearing loss. Around half of those affected may also experience cognitive issues like trouble concentrating, poor judgment, or issues with memory.

Unfortunately, there is no cure for MS. However, the condition can be managed with other interventions.

If you have MS and are looking for support, consider looking at the resources from the National Multiple Sclerosis Society.