Zeposia (ozanimod), formerly known as RPC1063, is an approved 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).
It comes in 0.92 mg capsules designed to be taken orally once a day.
The U.S. Food and Drug Administration (FDA) approved Zeposia on March 26, 2020; however, due to the COVID-19 pandemic, Bristol Myers Squibb has delayed its arrival in clinics. It is not yet known when it will be made available.
The European Medicines Agency (EMA) also has accepted a new drug application for ozanimod for the treatment of RRMS. It will likely announce its decision in the first half of 2020.
How does Zeposia work?
In MS, inflammation caused by the body’s immune system can result in damage to the myelin sheath. The myelin sheath is essential to protect and insulate 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. Findings showed that ozanimod was effective in reducing total brain lesions, determined by magnetic resonance imaging (MRI) scans, after 24 weeks of treatment. Results of a nearly two-year safety and efficacy extension study further supported the potential of ozanimod in treating patients with RRMS. Common side effects were mostly minor. They included nasopharyngitis, respiratory tract infections, urinary tract infections, and headaches. 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). 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. It 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 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) with Avonex in 1,346 RRMS patients. Treatment with ozanimod, at either dose, produced both statistically significant and clinically meaningful improvements in patients compared with Avonex. People given ozanimod also showed significant and meaningful improvements in the trial’s secondary objectives at month 12, and again at month 24. Formal study results appeared in the journal The Lancet Neurology in November 2019.
Ongoing clinical trials
A 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. Participants receive 1 mg oral doses of ozanimod daily until the end of the trial, the estimated completion date of which is June 2020.
A Phase 3 open-label trial (NCT04140305) called ENLIGHTEN is recruiting patients in multiple U.S. states and will soon include more states, as well as Puerto Rico. It aims to investigate changes in cognitive processing speed over a three-year period in an estimated 250 participants. Patients will receive 1 mg oral doses of ozanimod daily while being tested periodically using the symbol digital modalities test (SDMT) for changes in cognition. The estimated completion date of the study is October 2024.
Last updated: March 26, 2020
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