New drug for ulcerative colitis (UC)! Oral S1P receptor modulator Zeposia: with continuous treatment for 1 year, the disease has no recurrence rate of 86.1%!

October 25, 2022 /BioValleyBIOON/ -- Bristol-Myers Squibb (BMS) has unveiled new post-hoc analysis data
from the anti-inflammatory drug Zeposia (ozanimod) in the treatment of moderately to severely active ulcerative colitis (UC) Phase 3 True North (NCT02435992) at the annual scientific meeting of the American Society of Gastroenterology (ACG).
The study assessed the duration
of response after one consecutive year of Zeposia treatment, as well as after treatment interruption.

Zeposia is an oral drug, taken once daily, which is a sphingosine-1-phosphate (S1P) receptor modulator that selectively binds S1P subtypes 1 (S1P1) and 5 (S1P5)
with high affinity.
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 for the treatment of UC.

Data presented at the meeting showed that after achieving a clinical response at the end of the induction period (10 weeks), 86.
1% of patients still treated with Zeposia did not have a recurrence of disease at week 52 (Kaplan-Meier [KM] estimated recurrence-free rate at week 52: Zeposia/Zeposia, 86.
1%; Zeposia/placebo, 62.
6%)
.

Because temporary interruptions of treatment may occur in clinical practice, these analyses assess the duration of the
response after interruption of treatment.
The findings suggest that Zeposia maintained disease control for up to 8 weeks in patients who switched to placebo after achieving an initial clinical response to Zeposia (KM-estimated 8-week disease-free recurrence rate: Zeposia/Zeposia, 96.
1%; Zeposia/placebo, 90.
6%)
.

Other analyses presented at the meeting also showed that no other safety signals
were observed after 2 consecutive years of Zeposia treatment.

Bruce E.
Sands, chief of the Department of Gastroenterology at Mount Sinai Health System and professor of gastroenterology at the Icahn School of Medicine at Mount Sinai, said, "Understanding the duration of response after continuing Zeposia treatment is critical because it helps support clinical decision-making
when temporary discontinuation of UC treatment is considered in clinical practice.
These analyses reconfirmed that Zeposia treatment was effective in helping patients keep their disease relapse-free and showed that most patients remained relapse-free
for 8 weeks after treatment was interrupted.
”

Jonathan Sadeh, senior vice president of immunology and fibrosis development at BMS, said: "The data presented at the ACG meeting show that Zeposia prevents disease recurrence after one year of continuous treatment, maintaining disease control
even with temporary interruptions.
These analyses reinforce Zeposia's established profile in patients with moderately to severely active UC and underscore our long-term commitment to
the gastrointestinal community.
”

ozanimod molecular structure (Image source: Wikipedia)

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by an abnormal immune response that lasts for a long time, producing long-term inflammation and ulceration (ulceration) in the mucous membrane (lining)
of the large intestine (colon).
Symptoms include bloody stools, severe diarrhea, and frequent abdominal pain, which usually appear
over time rather than suddenly.
UC has an important impact on patients' health-related quality of life, including physical functioning, social and emotional well-being, and ability to
work.
Many patients do not respond adequately or at all to currently available therapies
.
An estimated 12.
6 million people worldwide have IBD
.

Zeposia is an oral sphingosine-1-phosphate (S1P) receptor modulator that selectively binds S1P subtypes 1 (S1P1) and 5 (S1P5)
with high affinity.
Zeposia is able to reduce the ability of lymphocytes to migrate from lymphoid tissues, reducing the number of
circulating lymphocytes in the peripheral blood.
The mechanism by which Zeposia exerts a therapeutic role in ulcerative colitis (UC) is unknown, but may involve reducing the migration
of lymphocytes to the intestine.

Bristol-Myers Squibb is continuing to evaluate the long-term efficacy and safety
of Zeposia for the treatment of moderately to severely active UC in the True North Open-Label Extension (OLE) trial.
The company is also evaluating Zeposia for the treatment of moderately to severely active Crohn's disease (CD)
in a Phase 3 YELLOWSTONE clinical trial program.

In the United States, in March 2020, Zeposia received FDA approval for the treatment of recurrent multiple sclerosis (RMS) in adults, including clinically isolated syndromes, relapsing-remitting disease, and active secondary progressive disease
.
In May 2021, Zeposia received FDA approval for the treatment of adults with moderately to severely 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 radiographic features).
In November 2021, Zeposia received EC approval for the treatment of adult patients
with moderately to severely active UC who have underresponded, lost response, or intolerance to conventional treatment or biologics.
(Bio Valley Bioon.
com)

New Data Presented at the American College of Gastroenterology Annual Scientific Meeting Demonstrate Continuous Zeposia (ozanimod) Treatment Prevents Disease Relapse Over One Year in 86.
1% of Patients Who Respond at the End of the Induction Period