- In a phase III study in 1,346 people with relapsing MS, oral ozanimod (Celgene Corporation) significantly reduced the relapse rate compared with Avonex® (interferon beta-1a, Biogen), and reduced disease activity on MRI scans.
- The results were announced in a February 17 press release from Celgene Corporation. According to the press release, the company expects data from an additional phase III study to be available later this year.
Ozanimod is a selective sphingosine 1-phosphate receptor modulator. It is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system. In an earlier phase II trial, in 258 participants with relapsing MS, disease activity on MRI scans was reduced in people taking two different doses of ozanimod, compared to people taking placebo. (Lancet Neurology, 2016 Apr;15(4):373-81
For the phase III trial, all 1,346 participants were randomly assigned to one of three treatment groups, taking either daily oral ozanimod (.5 mg) and an inactive placebo injected into muscle once weekly; daily oral ozanimod (1 mg) and inactive placebo injected into muscle once weekly; or Avonex and an oral placebo daily for 12 months.
The primary outcome was relapse rate, measured at 12 months. Secondary outcomes included disease activity as observed on MRI scans. Results related to the time to onset of disability progression, as measured by the EDSS disability scale, will be evaluated in combination with results from another phase III trial still underway.
The study met the primary endpoint in reducing the relapse rate, as well as the secondary MRI endpoints. According to the press release, the overall safety and tolerability profile was similar to the phase II study, but no further information was provided. In the phase II study, the most common adverse events were respiratory infections, headache, and urinary tract infections.
Three serious adverse events occurred (optic nerve inflammation, a psychological disorder, and non-cancerous cervical cell changes) but were not considered to be related to treatment.
According to the press release, the company expects data from a second phase III trial to be available later this year.
“We look forward to seeing the full results of this study,” said Bruce F. Bebo, PhD, Executive Vice President, Research at the National MS Society. “We hope these results lead to a treatment advance for people living with relapsing MS.”