Ozanimod Superior to Avonex in Treating Relapsing MS in Phase 3 Trials, Celgene Reports

Celgene released the results of two Phase 3 trials showing that patients with relapsing multiple sclerosis (MS) who were treated with ozanimod had lower relapse rates and fewer MRI brain lesions compared to those given a current first-line therapy, Avonex (interferon β-1a).

These results will be used to support a request for ozanimod’s approval as an MS therapy  with the U.S. Food and Drug Administration (FDA), a filing known as a  New Drug Application.

The therapy — invented by scientists at The Scripps Research Institute (TSRI) in San Diego — selectively targets two receptors, the sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5), and shows similar action to the Avonex, an intramuscular injection of interferon beta-1a marketed by Biogen.

S1PR1 and S1PR5 receptors are located at the surface of certain immune cells, and blocking them is a way of curtailing the inflammatory process.

The Phase 3 RADIANCE Part B (NCT02047734) study goal was to determine the annualized release rate in relapsing MS patients treated with one of two doses of oral ozanimod — 1 mg and 0.5 mg — administered daily and compared to patients who received an Avonex weekly injection. All were evaluated over a two-year treatment period. The study enrolled 1,320 patients with relapsing MS at 147 sites in 21 countries.

In the Phase 3 SUNBEAM trial (NCT02294058), researchers measured the annualized relapse rate after patients received the same doses of oral ozanimod (1 mg or 0.5 mg) for at least one year, compared to those given Avonex. The multicenter, international study enrolled 1,346 patients in 20 countries.

Data from these studies showed that both doses of ozanimod significantly reduced the annualized relapse rate, and the reduction was superior to that achieved with Avonex.

A significant reduction in the number of gadolinium-enhanced MRI lesions and new or enlarging T2 lesions after one year of treatment was also observed in ozanimod-treated patients relative to those treated with Avonex.

Finally, both doses of the therapy significantly slowed brain volume loss — a feature that signals disease progression and cognitive impairment — compared to Avonex.

“Ozanimod’s ability to inhibit brain atrophy promises patients a long and productive life, living with relapsing, remitting multiple sclerosis without disability,” Hugh Rosen, MD, a TSRI professor of Molecular Medicine and co-inventor of ozanimod, said in a press release. “This is truly disease-modifying.”

Celgene hopes to have ozanimod available to patients by late 2018, pending FDA approval.

Ozanimod was discovered and first developed in an academic setting, as part of the National Institutes of Health’s (NIH) Molecular Library Initiative, and is the first such discovery to successfully complete Phase 3 clinical trials.

“The success of ozanimod shows that academia and the NIH can make transforming discoveries that benefit patients and those that care for them,” Rosen said.

Celgene is also evaluating ozanimod’s potential in other diseases, including autoimmune and rheumatological conditions. Currently, the company has ongoing Phase 3 trials for ulcerative colitis, and recently released data from a Phase 2 study in Crohn’s disease.