Analysis Showed Oral Ozanimod Reduced Brain Volume Loss Across All Age Subgroups in Adults with Relapsing Multiple Sclerosis
Celgene Corporation (NASDAQ:CELG) today announced the results of a post-hoc analysis of data from the Phase 3 RADIANCE™ Part B trial showing that ozanimod reduced cortical grey matter volume loss versus first-line treatment, Avonex® (interferon beta-1a), in adults with relapsing multiple sclerosis (RMS) across all age groups, including patients ages 18 to 25. The analysis will be presented at the 2019 American Academy of Neurology (AAN) Annual Meeting in Philadelphia, May 4-10, 2019.
“Brain volume loss is associated with long-term physical disability and cognitive issues in multiple sclerosis,” 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 the analysis. “Ozanimod reduced the loss of cortical grey matter volume across all age groups in this study.”
RADIANCE evaluated two doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI respectively) compared with interferon beta-1a in 1,313 patients with RMS between the ages of 18 and 55 years old. In this post-hoc analysis of 874 patients, treatment effect on serial brain volume, including thalamic volume and cortical grey matter, was evaluated by patient age (18 to 25, n=146; 26 to 34, n=265; 35 and older, n=463) at baseline, 12 months and 24 months.
Patients in the 18 to 25 age group tended to have greater brain volume at baseline but more active disease as measured by gadolinium-enhancing MRI lesions. There was also a trend for this age group to experience greater whole brain volume loss at both 12 and 24 months compared with the older groups.
Patients across all age groups treated with ozanimod lost less cortical grey matter volume than did those treated with interferon beta-1a over 24 months, including patients in the 18 to 25 age group.
In the RADIANCE Part B trial, the most common adverse reactions (≥ 5 percent) that were higher with ozanimod than with interferon beta-1a were upper respiratory tract infections, urinary tract infections, increases of alanine aminotransferase and increases of gamma-glutamyl transferase.
“Since loss of brain volume can be associated with disease progression, there is a need for early diagnosis and treatment in multiple sclerosis,” said Alise Reicin, M.D., President, Global Clinical Development for Celgene. “This analysis adds to growing evidence supporting the potential use of ozanimod to treat adults with relapsing multiple sclerosis, including the youngest patients studied, who also showed the most rapid loss in brain volume in this study.”
Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Ozanimod is an investigational compound that is not approved for any use in any country.
Celgene submitted a New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in March 2019 for ozanimod for the treatment of adults with RMS.
About RADIANCE™ Part B
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 1,313 people living with RMS across 150 sites in 21 countries.
The primary endpoint of the trial was annualized relapse rates (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 whole brain volume at month 24. Cortical grey and thalamic volume changes were also prospectively assessed versus active comparator.
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 an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Ozanimod causes lymphocyte retention in lymphoid tissues. The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve the reduction of lymphocyte migration into the central nervous system.
Ozanimod is in development for immune-inflammatory indications including RMS, ulcerative colitis and Crohn's disease.
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. MS affects approximately 400,000 people in the U.S. and approximately 2.5 million people worldwide.
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, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: management’s time and attention is diverted on transaction related issues; disruption from the transaction make it more difficult to maintain business, contractual and operational relationships; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company could delay or prevent the proposed transaction; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel.
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