Study met its primary endpoint in reducing annualized relapse rate (ARR) and measured secondary endpoints, compared to interferon (IFN) β-1a (Avonex®)
Safety and tolerability consistent with phase II studies
Confirmatory phase III RADIANCE trial data expected in Q2 of 2017
SUNBEAM evaluated two orally administered treatment doses (0.5 mg and 1 mg) of ozanimod, with patients treated for at least one year. The randomized phase III trial enrolled 1,346 RMS patients in 20 countries.
Top-line data show that both the ozanimod 1 mg and 0.5 mg treatment arms
demonstrated statistically significant and clinically meaningful
improvements compared to Avonex® for the primary endpoint of ARR and the
measured secondary endpoints of the number of gadolinium-enhancing MRI
lesions and the number of new or enlarging T2 MRI lesions at month 12.
As agreed to in the Special Protocol Assessment (SPA) with the
The overall safety and tolerability profile was consistent with results from previously reported phase II RMS (RADIANCE) and phase II ulcerative colitis (TOUCHSTONE) trials.
"The safety and efficacy results from SUNBEAM are consistent with the
long-term results from the phase II trial (RADIANCE). These data add to
the growing body of evidence supporting the use of ozanimod as a disease
modifying therapy for relapsing forms of multiple sclerosis," said
"People living with multiple sclerosis need additional therapies and we
are pleased that oral ozanimod showed meaningful improvements across
primary and measured secondary endpoints in this study," said
SUNBEAM is a phase III multicenter, randomized, double-blind, double-dummy, active-controlled study assessing the efficacy, safety and tolerability of two orally administered doses of ozanimod (0.5 mg and 1 mg) against weekly intramuscular interferon beta-1a (Avonex®) over a minimum of a 12-month treatment period. The study included 1,346 RMS patients across 152 sites in 20 countries.
The primary endpoint of the active comparator trial is ARR during the treatment period. The measured secondary endpoints are: the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months and the number of GdE brain MRI lesions at month 12. The time to onset of disability progression as defined by a sustained worsening in EDSS of 1.0 points or more, confirmed after 3 months and 6 months, will be analyzed as part of a pre-specified pooled analysis of SUNBEAM and RADIANCE data.
Ozanimod is a novel, oral, selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis, ulcerative colitis and Crohn's disease. Selective binding with S1PR1 receptors is believed to inhibit a specific sub set of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity. Importantly, immune surveillance is maintained.
Selective binding with S1PR5 receptors is believed to activate specific cells within the CNS. This has the potential to enhance remyelination and prevent synaptic defects. Ultimately, neurological damage may be prevented.
Ozanimod is an investigational compound that is not approved for any use in any country.
About Multiple Sclerosis
Multiple sclerosis is a disease in which the immune system attacks the
protective myelin sheath that covers the nerves. The myelin damage
disrupts communication between the brain and the rest of the body.
Ultimately, the nerves themselves may deteriorate — a process that's
currently irreversible. Signs and symptoms vary widely, depending on the
amount of damage and the nerves affected. Some people with severe
multiple sclerosis may lose the ability to walk independently, while
others experience long periods of remission during which they develop no
new symptoms. Multiple sclerosis affects approximately 400,000 people in
RMS is characterized by clearly defined attacks of worsening neurologic function. These attacks — often called relapses, flare-ups or exacerbations — are followed by partial or complete recovery periods (remissions), during which symptoms improve partially or completely, and there is no apparent progression of disease. RMS is the most common disease course at the time of diagnosis. Approximately 85 percent of people are initially diagnosed with relapsing multiple sclerosis, compared with 10-15 percent with progressive forms of the disease.
This press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans," "will," "outlook" and
similar expressions. Forward-looking statements are based on
management's current plans, estimates, assumptions and projections, and
speak only as of the date they are made.
Patrick E. Flanigan III
Corporate Vice President, Investor Relations
Senior Director, Corporate Communications
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