Celgene's investigational MS drug ozanimod meets main goal of Phase III study

Celgene on Monday announced that the experimental drug ozanimod achieved the primary endpoint of a late-stage study in patients with relapsing multiple sclerosis. Terrie Curran, president of inflammation and immunology at the company, remarked "we plan to begin submitting global registration dossiers by the end of the year."

The RADIANCE trial randomised 1313 patients with relapsing multiple sclerosis to receive treatment with one of two doses of oral ozanimod or Biogen's Avonex (interferon beta-1a) weekly over a 24-month period. In addition to the primary endpoint of annualised relapse rate over 24 months, key secondary goals included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over the study period and the number of gadolinium-enhancing brain MRI lesions at month 24.

Celgene noted that both doses of ozanimod demonstrated significant and clinically meaningful reductions in the annualised relapse rate versus Avonex, while the oral selective S1P 1 and 5 receptor modulator also achieved significance for the two key secondary endpoints. However, the company said that in a pre-specified pooled analysis of data from the RADIANCE trial and the previously reported late-stage SUNBEAM study, ozanimod was not associated with a significant difference in the rate of disease progression versus Avonex. The drugmaker indicated that the rates of disease progression were extremely low across all three arms in the RADIANCE study, adding that further data analyses are ongoing, with detailed results expected to be presented at a future research conference.

FirstWord reports in this therapy area - KOL Insight Multiple Sclerosis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Shares in Celgene declined slightly on the news, with Evercore ISI analyst Umer Raffat suggesting that investors were focused on whether ozanimod reduced the rate of disease progression versus Avonex. Celgene gained rights to ozanimod via its $7.2-billion acquisition of Receptos in 2015. The drugmaker is also developing the therapy for the treatment of other immune-inflammatory conditions such as ulcerative colitis and Crohn's disease.

For related analysis, see ViewPoints: Can Celgene's ozanimod offer anything different in multiple sclerosis? – the jury remains out.

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