"Reduce Damage + Enhance Repair": Bristol Myers Squibb’s Zeposia Demonstrates Long-Term Efficacy and Safety in Relapsing Multiple Sclerosis

September 02, 2020 /Bio ValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently announced at the 8th Joint ACTRIMS-ECTRIMS MSVirtual2020 ConferenceConferenceInterim results from the Phase 3 open-label extension DAYBREAK trial of the new multiple sclerosis drug Zeposia (ozanimod) were published, confirming the long-term efficacy and safety of Zeposia in patients with relapsing forms of multiple sclerosis (RMS): most patients remained relapse-free at 24 and 36 months of treatment, with no new safety concerns identified.

It is worth noting that the DAYBREAK trial represents the longest-term safety and efficacy analysis of Zeposia in patients with RMS to date. The trial included 2,494 patients who had previously completed Phase 1, Phase 2, and Phase 3 studies of Zeposia.Clinical Trial, the mean treatment duration in the DAYBREAK trial was 35.4 months.

The results showed that long-term use of Zeposia did not reveal any new safety concerns in this extension study.At 24 and 36 months of treatment, 79% and 75% of patients were recurrence-free.. Furthermore,Only 10.8% and 8.6% of patients experienced confirmed disability progression (CDP) at 3 months and 6 months, respectively.Regardless of the treatment arm in the parent trials (RADIANCE, SUNBEAM, and RPC01-1001 clinical studies), the mean number of new or enlarging T2 lesions was similar at Month 24 of treatment, as was the mean number of gadolinium-enhancing (GdE) lesions at Month 24.

In the DAYBREAK trial, 2,494 patients were exposed to Zeposia for 35.4 months, among whom 2,039 patients (81.8%) experienced treatment-emergent adverse events (TEAEs), 236 patients (9.5%) experienced serious TEAEs (SAEs), and 56 patients (2.2%) discontinued the study due to TEAEs. The most common TEAEs were nasopharyngitis (17.9%), headache (14%), upper respiratory tract infection (9.9%), and lymphopenia (9.6%). No serious opportunistic infections have been reported to date, and the exposure-adjusted incidence rates of TEAEs and SAEs decreased over time.

Bruce Cree, the study’s principal investigator and a professor of clinical neurology at the Weill Institute for Neurosciences at the University of California, San Francisco, stated:“Gaining a deeper understanding of long-term treatment outcomes enables clinicians to determine the most appropriate therapy for patients with multiple sclerosis. The DAYBREAK trial provides us with important context regarding the long-term efficacy and safety of Zeposia.”

Mary Beth Harler, M.D., Head of Immunology and Fibrosis Development at Bristol-Myers Squibb, stated: “At MSVirtual2020, we are pleased to share new findings from DAYBREAK and a broad range of research outcomes that accelerate our understanding of relapsing forms of multiple sclerosis (MS) and add to the growing body of knowledge on Zeposia. In collaboration with our industry-leading partners, we are investigating novel endpoints, brain volume, and cognitive function, which may help further elucidate the safety and efficacy of Zeposia and advance translational science for patients living with this unpredictable and debilitating disease.”

Multiple Sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath covering nerves. Damage to the myelin sheath can disrupt communication between the brain and other parts of the body. Eventually, the nerves themselves may deteriorate, a process that is currently irreversible. Multiple sclerosis affects approximately 2.5 million people worldwide and about 700,000 people in Europe.

The active pharmaceutical ingredient of Zeposia, ozanimod, is an oral sphingosine-1-phosphate (S1P) receptor modulator that selectively binds to S1P1 and S1P5 receptors with high affinity. The selective binding of ozanimod to S1P1 is believed to inhibit the migration of a specific subset of activated lymphocytes into inflammatory sites, thereby reducing circulating levels of T and B lymphocytes and exerting anti-inflammatory effects by mitigating immune-mediated attacks on neural myelin. Due to its unique mechanism of action, ozanimod preserves patients’ immune surveillance capabilities. Furthermore, the binding of ozanimod to S1P5 activates specialized cells within the central nervous system, promoting remyelination and preventing synaptic defects, ultimately safeguarding against neural damage. Through the combined mechanisms of “reducing damage” and “enhancing repair,” ozanimod has the potential to alleviate symptoms in various immune-mediated disorders.

In the United States, Zeposia was approved in March this year for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. In the European Union, Zeposia was approved in May this year for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease (defined by clinical or imaging features).

Clinical data show that, compared with Avonex (interferon beta-1a), Zeposia reduced the annualized relapse rate (ARR) by 48% relative to Avonex after one year of treatment and by 38% after two years. Compared with Avonex, Zeposia also reduced the number of brain lesions and lesion size, demonstrating a smaller percentage change from baseline in whole-brain volume (WBV).

Zeposia was developed by Celgene. This drug also marks the first asset approved in the United States and the European Union since Bristol-Myers Squibb completed its acquisition of Celgene, expanding Bristol-Myers Squibb's presence inImmunologyexclusive rights in the field. (Bioon.com)

Original Source: Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis