Bristol Myers Squibb Highlights Sustained Efficacy and Favorable Safety of Oral S1P Receptor Modulator Zeposia in Long-Term Treatment of Ulcerative Colitis

News on February 17, 2022 /BioValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently announced interim results from the True North open-label extension study (OLE, NCT02531126) at the 17th Congress of the European Crohn's and Colitis Organisation (ECCO). The study is evaluating the long-term efficacy and safety of the anti-inflammatory drug Zeposia (ozanimod) in patients with moderate to severe active ulcerative colitis (UC). The results showed,The proportion of patients achieving clinical remission, clinical response, endoscopic improvement, and corticosteroid-free remission was maintained through Week 142.No new safety signals emerged in the study.

Zeposia is an oral medication taken once daily. It is a sphingosine-1-phosphate (S1P) receptor modulator that selectively binds with high affinity to S1P subtypes 1 (S1P1) and 5 (S1P5). In the United States and the European Union, Zeposia has been approved for the treatment of multiple sclerosis (MS) and ulcerative colitis (UC). Notably,Zeposia is the first oral S1P receptor modulator approved in the U.S. and EU for the treatment of UC.

Patients (n=823) enrolled in the True North Open-Label Extension (OLE) study, who previously participated in the phase 3 True North Zeposia study.Clinical Trial. This meeting announced the inspection of the interim analysis data for these patients. InAt weeks 46, 94, and 142, 45% (203/452), 51% (109/213), and 45% (39/87) of patients were in clinical remission, and 80% (352/441), 84% (176/209), and 86% (73/85) were in clinical response, respectively.

Among patients who entered this long-term study as responders on OLE Study Day 1, the efficacy of Zeposia was higher than in the overall population, with 70% (107/152) and 69% (42/61) in clinical remission at Weeks 46 and 94, respectively, and 95% (145/152) and 98% (60/61) in clinical response at Weeks 46 and 94, respectively.

In this analysis, of the 823 patients from the phase 3 True North trial who entered the open-label extension study, 64% subsequently completed week 46, 34% completed week 94, and 14% completed week 142. The most common reason for discontinuation was lack of efficacy (21%). Among the pooled population of 1,158 patients (including the phase 2 Touchstone study and phase 3 True North study), no new safety signals were identified with long-term use of Zeposia.

Jonathan Sadeh, Senior Vice President of Immunology and Fibrosis Development at Bristol-Myers Squibb, stated: "These long-term treatment data reinforce the growing body of evidence supporting the sustained efficacy and safety of Zeposia, and highlight Zeposia's role as a significant treatment option for patients with moderate to severe active ulcerative colitis prior to the use of biologics and JAK inhibitors."

Ozanimod Molecular Structure (Image Source: Wikipedia)

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD), characterized by an abnormal immune response, prolonged duration, and long-term inflammation and ulcers in the mucosa (lining) of the large intestine (colon). Symptoms include bloody stools, severe diarrhea, and frequent abdominal pain, which typically develop over time rather than suddenly. UC significantly impacts health-related quality of life, including physical function, social and emotional well-being, and work capacity. Many patients respond inadequately or not at all to currently available therapies. It is estimated that 12.6 million people worldwide suffer from IBD.

The active pharmaceutical ingredient ozanimod in Zeposia is an oral sphingosine-1-phosphate (S1P) receptor modulator that selectively binds with high affinity to S1P subtype 1 (S1P1) and 5 (S1P5).

In the United States, in March 2020, Zeposia received FDA approval: for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. In May 2021, Zeposia receivedFDAApproval: For the treatment of adult patients with moderate to severe active UC.

In Europe, in May 2020, Zeposia received approval from the European Commission (EC) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease (defined as: having clinical or imaging features). In November 2021, Zeposia received EC approval for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologics.

Currently, Bristol-Myers Squibb is developing Zeposia for various immune-inflammatory indications, including Crohn's disease (CD) in addition to multiple sclerosis (MS) and ulcerative colitis (UC). Phase III YELLOWSTONEClinical TrialThe project is evaluating Zeposia for the treatment of patients with moderate to severe active CD. The mechanism of Zeposia in treating UC and CD is not yet clear but may be related to reducing lymphocyte infiltration into the inflamed intestinal mucosa. (Bioon.com)

Source of Original Text:Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis