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New Analyses from Pivotal Phase III Trials of Oral Ozanimod in Relapsing Multiple Sclerosis To Be Presented at the 2018 American Academy of Neurology Annual Meeting - Reductions in annualized relapse rates shown in pivotal trials with ozanimod were consistent in subg…
  • 기사등록 2018-04-25 19:57:35
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[트리니티메디컬뉴스=신민철기자] Celgene Corporation (NASDAQ:CELG) today announced additional phase III data analyses evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1P1) and 5 (S1P5) receptor modulator, versus interferon beta-1a (IFN β-1a) (Avonex®) in patients with relapsing multiple sclerosis (RMS). These additional data analyses from the SUNBEAM™ and RADIANCE™ Part B trials are being presented at the 2018 American Academy of Neurology (AAN) Annual Meeting in Los Angeles, April 21-27, 2018.

“These new analyses of the pivotal SUNBEAM and RADIANCE Part B trials provide robust evidence that supports ozanimod as a potential new therapeutic option in a broad spectrum of patients with relapsing multiple sclerosis,” said Ludwig Kappos, M.D., Chair of the Department of Neurology at the University of Basel and a presenter of one of the abstracts. “The reduction in annualized relapse rates with ozanimod in these trials was consistent across a range of pre-specified subgroups versus interferon beta-1a.”

The phase III SUNBEAM and RADIANCE Part B studies evaluated two doses of oral ozanimod (1 mg and 0.5 mg ozanimod HCl) compared with IFN β-1a in patients with RMS. In the new analyses, several pre-specified subgroups, including disability severity at baseline (EDSS ≤3.5 vs. EDSS >3.5), presence of gadolinium-enhanced lesions at baseline and prior treatment with disease-modifying therapies, were assessed. Data from these analyses, to be presented in an oral session on April 25, show dose-dependent effects of ozanimod on annualized relapse rates (ARR) versus IFN β-1a across these subgroups that were consistent with the primary endpoint of both SUNBEAM and RADIANCE Part B.

A pair of poster presentations on April 24 examined reductions in brain volume loss, a measure associated with multiple sclerosis (MS) disease progression, for ozanimod compared with IFN β-1a. As previously reported for SUNBEAM at one year and for RADIANCE Part B at two years, whole brain volume loss was reduced relative to IFN β-1a for both the 1 mg dose of ozanimod and the 0.5 mg dose. For both doses, all comparisons were nominally significant.

Additional data in the presentations from exploratory endpoints examined volume loss of specific segments of the brain. Increasing evidence suggests that disease-related damage to grey matter is of major importance in MS. The data analyses to be presented show reductions in cortical grey matter loss and thalamic volume loss are consistent with the reductions in whole brain volume loss seen in SUNBEAM at one year for ozanimod compared with IFN β-1a. Likewise, reductions in cortical grey matter loss and thalamic volume loss are consistent with the reductions in whole brain volume loss seen in RADIANCE Part B at two years.

In the clinical trials, adverse reactions that occurred in at least 5 percent of patients in either ozanimod treatment group, with at least a 1 percent difference greater than the IFN β-1a group, were nasopharyngitis, headache, increased alanine aminotransferase, upper respiratory tract infection, hypertension, increased gamma-glutamyltransferase, pharyngitis and urinary tract infections.

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


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