Zeposia (ozanimod) is a treatment developed by Celgene, a subsidiary of Bristol Myers Squibb, to treat adults with relapsing forms of multiple sclerosis (MS) — both relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS) — as well as clinically isolated syndrome (CIS).
The U.S. Food and Drug Administration (FDA) approved Zeposia, formerly RPC1063, on March 26, 2020. However, due to the COVID-19 pandemic, Bristol Myers Squibb has delayed its arrival in clinics. It is not yet clear when the therapy will be available in the U.S.
The treatment comes in 0.92 mg capsules that patients take by mouth once a day.
How does Zeposia work?
In MS, inflammation can result in damage to the myelin sheath, an insulating layer around nerves that is essential for protecting nerve fibers in the brain and spinal cord.
Zeposia belongs to a class of medications known as selective sphingosine 1-phosphate (S1PR1) and 5 (S1PR5) receptor modulators. S1PR1 modulators interfere with S1P signaling and block immune cells from exiting the lymph nodes and entering tissues such as the brain and spinal cord. This way, fewer cells are available to attack the myelin sheath.
Zeposia in clinical trials
Celgene announced positive results from a Phase 2 clinical trial (NCT01628393) called RADIANCE in 2016. Those findings showed that the treatment was effective in reducing total brain lesions, determined by magnetic resonance imaging (MRI) scans, after 24 weeks of treatment.
The results of a nearly two-year safety and efficacy extension study, reported in 2018, further supported the potential of Zeposia in treating patients with RRMS.
Common side effects were mostly minor. They included nasopharyngitis, which involves inflammation of the nasal passages, respiratory tract infections, urinary tract infections, and headaches. The researchers reported no new safety or tolerability issues.
Zeposia’s approval was based on data from the Phase 3 portion of the RADIANCE study and another Phase 3 trial called SUNBEAM. Pooled data from these trials showed that the treatment significantly slowed brain atrophy compared with Avonex (interferon beta-1a), an injectable medication from Biogen approved by the FDA for MS. It led to similarly low rates of disability progression.
The Phase 3 portion of the RADIANCE study (NCT02047734) began in 2013 under a special protocol assessment with the FDA. The trial evaluated the efficacy, safety, and tolerability of two oral doses of ozanimod (0.5 mg and 1 mg) against weekly intramuscular (into-the-muscle) injections of Avonex or a placebo in approximately 1,200 RRMS patients older than age 2. Both ozanimod doses met the study’s primary endpoint of lowering annualized relapse rates.
Another Phase 3 trial (NCT02294058), called SUNBEAM, compared the safety and effectiveness of oral ozanimod (0.5 mg and 1 mg doses) to Avonex in 1,346 people with RRMS. Treatment with ozanimod, at either dose, produced both statistically significant and clinically meaningful improvements in patients compared with Avonex. Individuals taking ozanimod also showed significant and meaningful improvements in the trial’s secondary objectives at month 12, and again at month 24. The formal study results appeared in the journal The Lancet Neurology in November 2019.
Ongoing clinical trials
An ongoing, Phase 3, open-label extension study (NCT02576717) is further evaluating ozanimod’s safety and efficacy in RRMS patients who participated in earlier trials — an estimated 2,495 people worldwide. The participants receive 1 mg oral doses of ozanimod daily until the end of the trial. The researchers expect to complete the study in November 2022.
That trial is investigating changes in cognitive processing speed over a three-year period in an estimated 250 participants, ages 18-65. Individuals enrolled in the study will receive 1 mg oral doses of ozanimod daily. The researchers will test them periodically using the symbol digital modalities test (SDMT) for changes in cognition. The estimated completion date of the study is June 2025.
Last updated: Sept. 3, 2020
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