Celgene’s Phase III trial of ozanimod for RMS meets primary endpoint

22nd May 2017 (Last Updated May 22nd, 2017 18:30)

US-based biopharmaceutical firm Celgene has reported positive results from the Phase III RADIANCE clinical trial of ozanimod for the treatment of relapsing multiple sclerosis (RMS) patients.

US-based biopharmaceutical firm Celgene has reported positive results from the Phase III RADIANCE clinical trial of ozanimod for the treatment of relapsing multiple sclerosis (RMS) patients.

Ozanimod is an oral, investigational, selective modulator of S1P 1 and 5 receptors.

The trial met the primary endpoint of statistically significant and clinical decrease in annualised relapse rate (ARR), when compared with intramuscular weekly interferon (IFN) β-1a (Avonex).

The multi-centre, randomised, double-blind, double-dummy, active-controlled trial assessed the efficacy, safety and tolerability of 0.5mg and 1mg ozanimod for 24 months in 1,313 patients at 147 sites in 21 countries.

Celgene inflammation and immunology president Terrie Curran said: “We plan to begin submitting global registration dossiers by the end of the year to bring this oral therapy to patients with relapsing multiple sclerosis.”

The drug also demonstrated decrease in the key secondary endpoints of the number of new or enlarging T2 MRI lesions and the number of gadolinium-enhancing MRI lesions, compared to Avonex at 24 months.

Its overall safety and tolerability profile was found to be consistent with the previous Phase II and III trials.

“We plan to begin submitting global registration dossiers by the end of the year to bring this oral therapy to patients with relapsing multiple sclerosis.”

The rate of disability progression was however observed to be very low and did not reach the required statistical significance.

In February, Celgene reported positive top-line results from the multi-centre, randomised, double-blind, double-dummy, active-controlled Phase III SUNBEAM trial, which evaluated the same doses of ozanimod in 1,346 RMS patients at 152 sites in 20 countries.

Based on the results from the Phase III trials, the firm intends to submit a new drug application (NDA) for ozanimod to the US Food and Drug Administration (FDA) by the end of this year.