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.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?