Study met the primary endpoint of annualized relapse rate (ARR) and key secondary MRI endpoints of T2 and GdE lesions, compared to interferon (IFN) β-1a (Avonex®); a very low rate of disability progression observed across the three treatment groups in the pooled analysis; disability endpoint not met
Safety and tolerability consistent with prior phase II and III studies
New Drug Application submission to the
RADIANCE evaluated two doses (0.5 mg and 1 mg) of oral ozanimod, with
patients treated for two years. The trial enrolled 1,313 RMS patients in
21 countries. Both ozanimod 0.5 mg and 1 mg doses demonstrated
statistically significant and clinically meaningful reductions in the
primary endpoint of ARR and the key secondary endpoints of the number of
new or enlarging T2 MRI lesions over 24 months of treatment compared to
In a pre-specified pooled analysis of the time to confirmed disability progression in both the RADIANCE and SUNBEAM phase III trials, a very low rate of disability progression was observed across the three treatment groups, and ozanimod did not reach statistical significance compared to Avonex®. Additionally, both doses of ozanimod demonstrated statistically significant reductions in brain atrophy compared to Avonex® in each phase III trial.
The overall safety and tolerability profile was consistent with results from the recently completed phase III SUNBEAM RMS trial and previously reported phase II trials.
"The results of the phase III RADIANCE trial confirm the data observed
in SUNBEAM and are consistent with the long-term phase II RADIANCE
"We are excited by the results seen to-date across both pivotal trials,
which further validated ozanimod's promising benefit-risk profile
relative to current therapies," said
Further analyses of the RADIANCE trial are ongoing. In
RADIANCE is a pivotal, phase III multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ozanimod (0.5 mg and 1 mg) against weekly intramuscular interferon beta-1a (Avonex®) over a 24 month treatment period. The study included 1,313 RMS patients across 147 sites in 21 countries.
The primary endpoint of the trial is ARR over 24 months. The key secondary endpoints are: the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months and the number of GdE brain MRI lesions at month 24.
An analysis of the time to onset of disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE phase III trials.
SUNBEAM is a pivotal, phase III multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ozanimod (0.5 mg and 1 mg) against weekly intramuscular interferon beta-1a (Avonex®) over a 24 month treatment period. The study included 1,346 RMS patients across 152 sites in 20 countries.
The primary endpoint of the trial was ARR during the treatment period. The key secondary endpoints were: 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.
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, 908-673-9969
Corporate Vice President, Investor Relations
Senior Director, Corporate Communications
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