Oral Ozanimod TOUCHSTONE study in ulcerative colitis receives a UEGW
Week top abstract prize
BOUDRY, Switzerland–(BUSINESS WIRE)–Celgene International Sàrl, a wholly owned subsidiary of Celgene
Corporation (NASDAQ: CELG), today presented results from the maintenance
phase of the TOUCHSTONE phase 2 clinical trial of Ozanimod, an
investigational compound, in patients with moderate to severe ulcerative
colitis at the United European Gastroenterology (UEG) Week in Barcelona,
Spain. This abstract was awarded a UEG Week Top Abstract Prize, which is
given to the top five abstracts submitted to UEG Week.
The TOUCHSTONE trial evaluated the efficacy and safety of 0.5 mg and 1
mg doses of Ozanimod compared with placebo after eight weeks of
treatment (induction phase) in 197 patients with moderate to severe
ulcerative colitis. The primary endpoint was the proportion of patients
in remission at week 8. Secondary endpoints were: the proportion of
patients achieving a clinical response, the proportion of patients with
mucosal improvement and the change from baseline in Mayo score.
Previously reported results showed TOUCHSTONE met its primary endpoint
and secondary endpoints with statistical significance for patients on
the 1 mg dose of Ozanimod versus placebo in the 8-week induction phase.
The abstract, titled A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED
TRIAL OF OZANIMOD, AN ORAL S1P RECEPTOR MODULATOR, IN MODERATE TO SEVERE
ULCERATIVE COLITIS: RESULTS OF THE MAINTENANCE PERIOD OF THE TOUCHSTONE
STUDY, can be viewed here.
The week 32 results from TOUCHSTONE were previously presented at the
American College of Gastroenterology (ACG) Annual Scientific Meeting in
Honolulu, October 16-21.
“Data from the maintenance phase, together with those from the induction
phase of the TOUCHSTONE trial of Ozanimod are promising and warrant
further investigation in patients with ulcerative colitis,” said
Dr. William Sandborn, M.D., Professor of Medicine and Chief, Division of
Gastroenterology and Director, University of California San Diego
Inflammatory Bowel Disease Center.
“Patients with ulcerative colitis currently need new therapies,” said
Scott Smith, President, Celgene Inflammation & Immunology. “Based on
these results, and as part of our commitment to bringing innovative
medicines to this patient community, we look forward to continued study
of this novel therapeutic approach for ulcerative colitis in phase 3
About the Trial
TOUCHSTONE is a phase 2, randomized, double-blind, placebo-controlled
trial comparing the efficacy and safety of Ozanimod (also known as
RPC1063) with placebo in patients with moderate to severe active
ulcerative colitis. A total of 197 patients were randomized and treated
once daily with 1 mg Ozanimod (n=67), 0.5 mg Ozanimod (n=65) or placebo
(n=65) for 8 weeks (the induction phase). The primary endpoint was the
proportion of patients in remission (Mayo score ≤2, no subscore >1) at
week 8. Secondary endpoints were the proportion of patients achieving
clinical response (reduction in Mayo score of ≥3 and ≥30% with a
decrease in the rectal bleeding score of ≥1 or a rectal bleeding score
≤1), proportion of patients with mucosal improvement (endoscopy score
≤1) and the change in Mayo score. Safety assessments included ECG,
Holter monitoring, pulmonary function testing, optical coherence
tomography and AEs.
For the maintenance phase, patients who achieved a clinical response at
week 8 continued with their original treatment through week 32.
Ozanimod is a small molecule sphingosine 1-phosphate 1 and 5 receptor
modulator in development for immune-inflammatory indications including
relapsing multiple sclerosis and inflammatory bowel disease. Treatment
with S1P receptor modulators is believed to work by interfering with S1P
signaling and blocks the response of lymphocytes (a type of white blood
cell) to exit signals from the lymph nodes, sequestering them within the
nodes. The result is thought to be a downward modulation of circulating
lymphocytes and anti-inflammatory activity by inhibiting cell migration
to sites of inflammation.
Ozanimod is an investigational compound that is not approved for any use
in any country.
About Ulcerative Colitis
Ulcerative colitis is a chronic, relapsing condition triggered by an
abnormal, prolonged immune response that creates long-lasting
inflammation and ulcers (sores) in the mucosa (lining) of the large
intestine (colon). Symptoms usually develop over time, rather than
suddenly. The disease can be debilitating and can sometimes lead to
life-threatening complications. Ulcerative colitis is the most common
form of inflammatory bowel disease worldwide. About one in every 198
people in Europe and one in every 402 people in North America have
ulcerative colitis. In 2004, 2.1 million prescriptions were written to
treat ulcerative colitis, and 716,000 ambulatory care visits were
related to the disease. In 2010, there were 107,000 hospitalizations due
to ulcerative colitis.
Celgene International Sàrl, located in Boudry, Switzerland, is a
wholly-owned subsidiary and international headquarters of Celgene
Corporation. 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 gene and
protein regulation. For more information, please visit www.celgene.com.
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and research division of Celgene Corporation.
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Patrick E. Flanigan III, 908-673-9969
President, Investor Relations
Director, Corporate Communications