The company presented the results of the SUNBEAM trial at the ACTRIMS Forum 2018 convention in San Diego, Feb. 1-3. The presentation was titled “Ozanimod Demonstrates Efficacy and Safety in a Phase 3 Trial of Relapsing Multiple Sclerosis (SUNBEAM).” The trial confirmed the results of another Phase 3 study.
Ozanimod (RPC-1063) is an oral, once-a-day immunotherapy that blocks two protein receptors, sphingosine 1-phosphate 1 and 5. By blocking these receptors, which lie on the surface of immune cells, ozanimod suppresses the cells’ inflammatory response.
The multi-center, international, double-blind, Phase 3 trial (NCT02294058) involved 1,346 adults with relapsing MS. It compared ozanimod’s ability to reduce patients’ annualized relapse rate with that of injections of Biogen’s Avonex (interferon beta-1a) to muscle. Ozanimod was administered daily in one of two doses — 1 mg and 0.5 mg — and Avonex weekly, for at least 12 months.
Researchers also compared the therapies’ ability to reduce brains lesions and slow changes in brain volume. Lesions are areas where the nerve-cell-protecting myelin sheath has deteriorated. They show up on MRI scans.
The larger dose of ozanimod decreased patients’ relapse rate by 48 percent, compared with Avonex, and the smaller dose 31 percent, Celgene reported.
In addition, both ozanimod doses reduced the number of patients’ new or growing brain lesions, compared with Avonex. There are two categories of lesions. The T2 category refers to the total number of lesions. The T1 category refers to lesions where there is potential myelin damage.
The higher dose of ozanimod reduced the number of T2 lesions by 48 percent and the lower dose by 25 percent. The larger dose reduced T1 lesions by 63 percent and the smaller dose by 34 percent.
Ozanimod also slowed brain volume loss. In the thalamus, the higher dose led to it slowing the loss by 39 percent and the lower dose by 34 percent, compared with Avonex. In the cortex, the larger dose led to brain volume loss slowing by 84 percent and the smaller dose by 61 percent.
The treatment-related adverse events that patients experienced were mostly mild, with no cases of heart abnormalities, researchers said. Discontinuation rates due to side effects were low and similar between the ozanimod and Avonex groups, the team said.
“In this Phase 3 study, both ozanimod doses demonstrated superior efficacy vs IFN [interferon, Avonex] on relapse and MRI endpoints [measures],” including brain volume loss, the researchers wrote. “These efficacy, safety, and tolerability results demonstrate that ozanimod is a novel oral therapy with a favorable benefit-risk profile for patients with [relapsing] MS.”
An earlier Phase 3 trial, RADIANCE Part B (NCT02047734), also compared ozanimod and Avonex’s ability to reduce the manifestations of relapsing MS. As with the SUNBEAM trial, RADIANCE showed that ozanimod did a better job than Avonex at reducing annualized relapse rates and brain lesions and slowing brain volume loss.