New Analyses from Pivotal Phase 3 Trials of Oral Ozanimod to Be Presented at ECTRIMS 2018
Celgene Corporation (NASDAQ:CELG) today announced the results of two post hoc analyses of data from the phase 3 SUNBEAM™ and RADIANCE™ Part B trials, which evaluated the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1P1) and 5 (S1P5) receptor modulator, versus a first-line treatment, Avonex® (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS). These findings will be presented at ECTRIMS 2018.
“Slowed cognitive processing, which is common in multiple sclerosis, often impairs quality of life for people living with this chronic condition,” said Bruce Cree, M.D., Ph.D., M.A.S., Professor of Neurology at the University of California San Francisco (UCSF) Weill Institute for Neurosciences, Clinical Research Director at the UCSF MS Center and an author of both analyses. “The findings from these new analyses suggest that, when compared to interferon, ozanimod has a beneficial effect on processing speed.”
SUNBEAM evaluated two doses (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI respectively) of oral ozanimod in 1,346 patients with RMS treated for at least one year. A post hoc analysis of 12-month data from SUNBEAM to be presented today examined the effect of ozanimod on cognitive processing speed, based on performance on the Symbol Digit Modalities Test (SDMT). Benefits in SDMT score at month 12 were seen with ozanimod versus IFN (difference: 1.6; 95% confidence interval [CI]: 0.62, 2.56 for ozanimod 1 mg and 1.2; 95% CI: 0.19-2.13 for ozanimod 0.5 mg). More patients exhibited clinically meaningful (≥4-point) improvements in processing speed at month 12 with ozanimod 1 mg (rate ratio, 1.3; 95% CI: 1.05, 1.55) and 0.5 mg (1.2; 95% CI: 0.94, 1.40) versus IFN.
A second post hoc analysis on annualized relapse rates (ARR) and MRI lesions examined the effect of ozanimod in patients with early RMS compared with patients with more advanced disease. Early RMS was defined based on a composite baseline profile, including 3 years or less since diagnosis, an Expanded Disability Status Scale (EDSS) of 3.5 or less, and the use of one or no disease-modifying treatments. In the pooled phase 3 studies, two doses of oral ozanimod (1 mg and 0.5 mg) were evaluated compared with IFN in 2,659 patients treated for two years.
For patients with early RMS (n=1,392) in this analysis, ARR was lower at 12 months with ozanimod 1 mg (ARR=0.149) and ozanimod 0.5 mg (ARR=0.200) compared with IFN (ARR=0.285). ARR was also lower with ozanimod versus IFN in patients with more advanced RMS (n=1,267) (ozanimod 1 mg: 0.217; 0.5 mg: 0.277; IFN: 0.363).
Ozanimod also showed a reduction of MRI lesions in both early and more advanced RMS in this analysis. For patients with early RMS, the mean number of gadolinium-enhancing (GdE) lesions at 12 months was 0.263 with ozanimod 1 mg, 0.458 with ozanimod 0.5 mg and 0.656 with IFN. For those with more advanced RMS, the mean number of GdE lesions was 0.278, 0.323 and 0.915, respectively. Similarly, the mean number of new or enlarging T2 lesions at 12 months for patients with early RMS was 2.952 for ozanimod 1 mg, 3.744 for ozanimod 0.5 mg and 4.633 for IFN. For patients with more advanced RMS, the numbers were 2.514, 2.903 and 4.710, respectively.
“These analyses provide additional encouraging data for ozanimod in relapsing multiple sclerosis, from its potential to influence cognitive processing to showing results in patients with either early or more advanced forms of the disease,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “Ozanimod has the potential to offer the multiple sclerosis community a new oral option for the treatment of relapsing multiple sclerosis, and we continue to work with regulatory bodies in the U.S. and EU in our efforts to bring this treatment to patients.”
In the SUNBEAM and RADIANCE clinical trials, the most common adverse reactions (≥ 5 percent) that were higher with ozanimod than with IFN were upper respiratory tract infections, urinary tract infections, increases of alanine aminotransferase and increases of gamma-glutamyl transferase.
Ozanimod is an investigational compound that is not approved for any use in any country.
SUNBEAM is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI respectively) against weekly intramuscular interferon beta-1a (Avonex®) over a 12-month treatment period. The study included 1,346 people living with RMS across 152 sites in 20 countries.
The primary endpoint of the trial was ARR during the treatment period. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months, number of gadolinium-enhanced brain MRI lesions at month 12 and percent change from baseline in brain volume at month 12.
An analysis of the time to onset of 3-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase 3 trials.
RADIANCE Part B is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI respectively) against weekly intramuscular interferon beta-1a (Avonex®) over a 24-month treatment period. The study included 1,320 people living with RMS across 147 sites in 21 countries.
The primary endpoint of the trial was ARR over 24 months. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months, number of gadolinium-enhanced brain MRI lesions at month 24 and percent change from baseline in brain volume at month 24.
An analysis of the time to onset of 3-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase 3 trials.
Ozanimod is a novel, oral, selective, sphingosine 1-phosphate 1 (S1P1) and 5 (S1P5) receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis, ulcerative colitis and Crohn's disease.
Selective binding with S1P1 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 S1P5 is thought to activate specific cells within the central nervous system. This has the potential to enhance remyelination (when the body is able to repair damaged myelin after inflammation is reduced) and prevent synaptic defects. Ultimately, neurological damage may be prevented.
About Multiple Sclerosis
Multiple sclerosis (MS) 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 living with MS 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 the U.S. and approximately 2.5 million people worldwide.
Relapsing multiple sclerosis (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 with no apparent progression of disease. RMS is the most common disease course at the time of diagnosis. Approximately 85 percent of patients are initially diagnosed with RMS, compared with 10-15 percent with progressive forms of the disease.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next‐generation solutions in protein homeostasis, immuno‐oncology, epigenetics, immunology and neuro‐inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
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. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission.
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