Open-label extension of TOUCHSTONE study of
ozanimod showed continued symptom improvement through week 44 of
the extension
Safety and tolerability were consistent with
previous studies of ozanimod
Celgene International Sàrl, a wholly owned subsidiary of Celgene
Corporation (NASDAQ:CELG), today announced that data from the
open-label extension of the TOUCHSTONE phase 2 clinical trial of
ozanimod in patients with moderate to severe ulcerative colitis are
to be presented at the United European Gastroenterology Week (UEGW)
in Vienna, Austria and at the American College of Gastroenterology
(ACG) Annual Scientific Meeting in Las Vegas. Ozanimod is an
investigational selective S1P 1 and 5 receptor modulator.
“Since ulcerative colitis is a chronic condition, patients are
looking for treatments that can help them over the long term,” 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. “These encouraging findings suggest that
continued treatment with ozanimod shows evidence of durable
efficacy with an acceptable safety profile.”
TOUCHSTONE 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 active ulcerative colitis. Patients who achieved a clinical
response at week 8 continued with their original treatment through
week 32 in a maintenance phase. 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.
TOUCHSTONE participants in all three treatment arms entered the
open-label extension if they did not respond to treatment after the
induction phase, relapsed during the maintenance phase or completed
the maintenance phase (170 of the 197 patients). The objective of
the open-label extension phase is to evaluate the long-term
efficacy and safety of daily ozanimod 1 mg.
During the extension period, treatment with ozanimod 1 mg
resulted in a decrease in mean partial Mayo Score (pMS) in all
treatment arms. For patients who had been treated with ozanimod 0.5
mg during the double-blind portion of the study and were switched
to ozanimod 1 mg for the extension phase of the study, mean pMS
score decreased from 4.5 at entry into the extension period to 1.7
at week 44. For patients who had been initially treated with
ozanimod 1 mg and stayed on ozanimod 1 mg for the extension phase
of the study, mean pMS score decreased from 3.3 at entry into the
extension period to 1.9 at week 44. For patients who had been
initially treated with placebo and were switched to ozanimod 1 mg
for the extension phase of the study, mean pMS score decreased from
4.6 at entry into the extension period to 1.7 at week 44.
Treatment with ozanimod 1 mg in the extension phase also showed
a decrease in the proportion of patients with rectal bleeding and
moderate or severe diarrhea.
During the safety follow-up in the extension phase, which ranged
from 44 weeks to over two years, the most common adverse events
(>2.0 percent) noted in the extension period were ulcerative
colitis flare (5.9 percent), upper respiratory tract infection (4.1
percent), anemia (3.5 percent), nasopharyngitis (3.5 percent),
transaminase elevation (3.5 percent), back pain (2.9 percent),
arthralgia (2.4 percent) and headache (2.4 percent). No notable
cardiac, ophthalmologic or infectious TEAEs were observed.
Serious adverse events occurred in 16 of 170 patients (9.4
percent). Serious AEs occurring in two or more patients were anemia
(1.2 percent) and ulcerative colitis flare (2.4 percent).
Alanine aminotransferase and aspartate aminotransferase
elevations more than three times the upper limit of normal occurred
in 4 of 170 patients (2.4 percent); all elevations were
asymptomatic, less than five times the upper limit of normal,
transient and resolving during ongoing treatment.
“Findings from this extension study at week 44 showed
improvements in efficacy measures for patients who took ozanimod
throughout both the blinded study and the extension,” said Scott
Smith, President, Celgene Inflammation & Immunology. “We
recognize the strong need for innovative treatments that help
patients with inflammatory bowel disease achieve durable results.
We are committed to advancing additional transformational oral
treatment options for these patients.”
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 percent
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 adverse events.
For the maintenance phase, patients who achieved a clinical
response at week 8 continued with their original treatment through
week 32. In the open-label extension phase, all patients (n=170)
were treated with ozanimod 1 mg. The week 44 visit was completed by
131 patients.
About Ozanimod
Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1
and 5 receptor modulator in development for immune-inflammatory
indications including inflammatory bowel disease and relapsing
multiple sclerosis. Treatment with S1P receptor modulators is
believed to work by interfering with S1P signaling and preventing a
certain subtype (ccr7+) of lymphocytes (a type of white blood cell)
from exiting the lymph nodes and contributing to tissue
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.
About Celgene
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. Follow Celgene on Social
Media: @Celgene, Pinterest, LinkedIn, FaceBook and
YouTube.
Forward-Looking Statements
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. Celgene undertakes 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 Celgene’s
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 Celgene’s Annual Report on Form 10-K and our other
reports filed with the U.S. Securities and Exchange Commission.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161017005086/en/
Celgene CorporationInvestors:Patrick E. Flanigan III,
908-673-9969Corporate Vice President, Investor
RelationsorMedia:Catherine Cantone, 732-564-3592Senior Director,
Corporate Communications
Celgene (NASDAQ:CELG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celgene (NASDAQ:CELG)
Historical Stock Chart
From Apr 2023 to Apr 2024