Data from Ozanimod Clinical Development Program in Relapsing Forms of Multiple Sclerosis to Be Presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis

  • Data to be presented include analyses of long-term efficacy and safety of ozanimod in adults with relapsing forms of multiple sclerosis and effects on biomarkers of disease activity

Celgene Corporation (NASDAQ:CELG) today announced it will present 13 scientific abstracts, including new analyses from the Phase 3 ozanimod clinical development program in adults with relapsing forms of multiple sclerosis (RMS), at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, September 11-13, 2019. Ozanimod is an investigational oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).

“Celgene is committed to furthering our understanding of multiple sclerosis (MS) and the full potential of ozanimod,” said Terrie Curran, President, Global Inflammation and Immunology, Celgene. “We look forward to sharing these new analyses with the MS community, including data on the long-term efficacy and safety of ozanimod in adults with relapsing forms of MS.”

Ozanimod is an investigational compound that is not approved for any use in any country.

Abstracts for presentation include:

New Analyses from the Ozanimod Clinical Development Program

Abstract #P615: Ozanimod efficacy in RMS by baseline thalamic volume quartile: a post hoc exploratory analysis of Phase 3 RADIANCE (Poster Session 1; Wednesday, September 11, 5:15-7:15 p.m. CET; lead author: Jeffrey)

Abstract #P980: Effect of ozanimod on the relationship between changes in cognition and grey matter volume in RMS: a post hoc exploratory analysis of the Phase 3 SUNBEAM trial (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Schippling)

Abstract #P993: Absorption, metabolism, and excretion, in vitro pharmacology, and clinical pharmacokinetics of ozanimod, a novel sphingosine 1-phosphate receptor agonist (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Tran)

Abstract #P996: Effect of ozanimod on circulating leukocyte subtypes: data from a randomized, open-label, Phase 1 study in patients with relapsing multiple sclerosis (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Harris)

Abstract #P1031: Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: results from the DAYBREAK open-label extension study (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Steinman)

Abstract #P1047: Effect of ozanimod on neurofilament light chain level in relapsing multiple sclerosis: pooled results from Phase 2 and Phase 3 trials (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Harris)

Cohort Studies of Patients with Multiple Sclerosis in Sweden

Abstract #148: Cardiovascular disease in patients with multiple sclerosis: a nationwide cohort study in Sweden (Oral: Free Communication 2 – Comorbidities; Thursday, September 12, 9:18-9:30 a.m. CET; lead author: Piehl)

Abstract #P761: Risk of osteoporosis and fractures in patients with multiple sclerosis: a nationwide cohort study in Sweden (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Montgomery)

Abstract #P762: Infections in patients with multiple sclerosis: a nationwide cohort study in Sweden (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Montgomery)

Abstract #272: Risk of comorbidity in patients with multiple sclerosis: a nationwide cohort study in Sweden (Oral: Scientific Session 11 – Registry-based MS Research; Friday, September 13, 9:10-9:22 a.m. CET; lead author: Piehl)

Health Economics and Outcomes Research Data

Abstract #P1065: Treatment patterns among treatment-naive multiple sclerosis patients in a commercially insured US population (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Kantor)

Abstract #P1068: Systematic literature review and network meta-analysis of Ozanimod compared with other treatments in relapsing-remitting multiple sclerosis (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Tencer)

Abstract #EP1590: Number-needed-to-treat analysis and risk-benefit assessment of Ozanimod compared with first-line disease-modifying therapies for relapsing-remitting multiple sclerosis (ePoster; lead author: Kumar)

Abstracts can be found on the ECTRIMS website here.

Celgene will also host a satellite symposium, “The Evolution of MS Study Outcomes: Relevance to Clinical Practice Today,” exploring current trends in MS research and care, including the implementation of novel study endpoints in the clinic, magnetic resonance imaging (MRI) assessment of brain volume change and lesions, the use of patient-reported outcomes and cognition assessment to measure disability progression, and real-world data. The symposium will take place on September 11, 2019 from 12:30-1:30 p.m. CET.

A New Drug Application for ozanimod for the treatment of adults with RMS is currently under review by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act, the FDA has set its action date as March 25, 2020. The European Medicines Agency also accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis, with a regulatory decision in the European Union expected in the first half of 2020.

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