In patients with moderate to severe ulcerative
colitis, histologic improvement was greater with ozanimod 1 mg
versus placebo at weeks 8 and 32
A greater proportion of patients achieved
histologic remission at week 32 with ozanimod 1 mg versus
placebo
Data shared in oral presentation at the 11th
Congress of the European Crohn’s and Colitis Organisation
Celgene International Sàrl, a wholly owned subsidiary of Celgene
Corporation (NASDAQ: CELG), today announced that additional data of
exploratory endpoints from the TOUCHSTONE phase 2 clinical trial of
ozanimod in patients with moderate to severe ulcerative colitis
were presented at the 11th Congress of the European Crohn’s and
Colitis Organisation (ECCO) in Amsterdam. Ozanimod is an
investigational selective S1P 1 and 5 receptor modulator. These
results, included in a digital oral presentation, showed that
ozanimod 1 mg resulted in improvements in histologic features and
remission in patients treated over 32 weeks.
“It’s exciting to observe histologic improvements in patients
with ulcerative colitis who were treated with ozanimod. Clinical
research suggests that histologic improvements can be linked with
improved clinical outcomes in 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. “While often more difficult to measure,
endpoints such as histologic improvement or remission are emerging
as important treatment goals for patients and their
physicians.”
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. Histologic improvement and remission with
ozanimod at the same time points was assessed as an exploratory
endpoint. Biopsies were scored by a central pathologist blinded to
treatment and sequence. 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 histology results from the TOUCHSTONE study presented at
ECCO, histologic improvement, which was determined by assessing the
change from baseline in Geboes score (12.92 in ozanimod 1 mg, 14.36
in ozanimod 0.5 mg and 13.94 placebo; a decrease in absolute score
indicates an improvement), was significantly greater for the 1 mg
dose than for placebo at both week 8 [Geboes (-4.37 vs. -2.20,
p=0.0345)] and week 32 [Geboes (-5.50 vs. -2.24, p=0.0033)]. The
0.5 mg dose resulted in greater improvement than placebo but the
difference did not reach statistical significance at either time
point.
At week 8, although there was an apparent numerical dose
response in the proportion of patients reaching histologic
remission, defined as a Geboes score less than 2, there were no
significant differences. However at week 32, 31 percent (21/67) of
patients on ozanimod 1 mg achieved histologic remission compared
with 8 percent (5/65) on placebo (p=0.0006), and 23 percent (15/65)
of patients on ozanimod 0.5 mg achieved histologic remission
(p=0.0164 vs. placebo).
Adverse events (AEs) from the phase 2 study occurred in
26/67 (38.8 percent) patients in the ozanimod 1 mg arm, 26/65
(40.0 percent) in the ozanimod 0.5 mg arm and 26/65 (40.0 percent)
in the placebo arm. The most common AEs were worsening of
ulcerative colitis (3, 2 and 5 patients in the arms outlined above,
respectively) and anemia (0, 3 and 4 patients in the arms outlined
above, respectively). No AEs of special interest (cardiac,
pulmonary, ophthalmologic, hepatic or serious infection) were
reported during the induction or maintenance phase.
“These data suggest that in addition to benefits we’ve
previously seen, oral ozanimod could also help ulcerative colitis
patients achieve the important treatment goal of histologic
remission,” said Scott Smith, President, Celgene Inflammation &
Immunology. “We are committed to bringing innovative medicines and
different treatment options for patients with inflammatory bowel
disease and continue to actively advance the phase 3 clinical
program for ozanimod.”
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 adverse events.
For the maintenance phase, patients who achieved a clinical
response at week 8 continued with their original treatment through
week 32.
About Ozanimod
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 blocking 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
a reduction of circulating lymphocytes that leads to
anti-inflammatory activity by inhibiting migration of pathologic
lymphocytes 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.
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
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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 Corporation 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 other reports
filed with the U.S. Securities and Exchange Commission.
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For Celgene CorporationInvestors:Patrick E. Flanigan III,
908-673-9969Vice President, Investor RelationsorMedia:Catherine
Cantone, 732-564-3592Senior Director, Corporate Communications
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