Takeda & TiGenix Announce Publication in The Lancet of 24-Week Results of the Phase 3 ADMIRE-CD Trial Investigating Cx601 in the Treatment of Complex Perianal Fistulas in Patients with Crohn's Disease
(Thomson Reuters ONE) -
PRESS RELEASE
Takeda and TiGenix Announce Publication in The Lancet of
24-Week Results of the Phase 3 ADMIRE-CD Trial Investigating Cx601 in the
Treatment of Complex Perianal Fistulas in Patients with Crohn's Disease
Osaka, Japan, August 2, 2016, and Leuven, Belgium, August 2, 2016, 08:00h CEST -
Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") and TiGenix NV
(Euronext Brussels: TIG) ("TiGenix") today announced that the 24-week results of
the Phase 3 ADMIRE-CD trial investigating Cx601 have been published in The
Lancet.(1) Cx601 is a suspension of allogeneic adipose-derived stem cells (eASC)
injected intra-lesionally for the treatment of complex perianal fistulas in
patients with Crohn's disease with an inadequate response to at least one
conventional or biologic therapy.
The ADMIRE-CD trial is a randomized, double-blind, placebo-controlled, Phase 3
study, designed to investigate the efficacy and safety of a single treatment of
Cx601 for the treatment of complex perianal fistulas in Crohn's disease
patients. A significantly greater proportion of patients in the Cx601 group
versus the placebo group achieved the primary endpoint of combined remission
(defined as clinical assessment of closure of all treated external openings
draining at baseline, despite gentle finger compression, and absence of
collections >2cm confirmed by MRI) at week 24 in the ITT population 53 (50%) of
107 vs 36 of 105 (34%), respectively (97.5% CI 0.2-30.3; p=0.024) and the mITT
population 53 (51%) of 103 vs 36 (36%) of 101 (0.5-31.2; p=0.021). These results
were confirmed in the per-protocol population and in additional supportive and
sensitivity analyses. This definition of remission is more stringent than those
commonly used in clinical trials on perianal fistulizing disease, as it includes
both clinical and radiological assessment by MRI.(2,3) Treatment-emergent
adverse events (non-serious and serious) and discontinuations due to adverse
events were comparable between Cx601 and placebo arms.
In addition, severity of perianal Crohn's disease was assessed at baseline and
all study visits with the Perianal Disease Activity Index (PDAI). In the mITT
population, the PDAI score was similar in the Cx601 and the placebo groups at
baseline. The improvement in PDAI with Cx601 was significantly greater than
placebo at week 6, 12 and 18. In addition, the mean total PDAI score at week 24
with Cx601 (4.4) was close to the threshold for inactive perianal disease
(PDAI<4) at which patients do not need medical or surgical treatment.
Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract
that affects approximately five million patient's worldwide.(4) People living
with Crohn's disease often experience complex perianal fistulas for which there
are limited treatment options. Recognizing the debilitating nature of the
disorder and the lack of treatment options, in 2009 the European Commission
granted Cx601 orphan designation for the treatment of complex perianal fistulas
in Crohn's disease. In March 2016, TiGenix announced that it submitted the
Marketing Authorization Application (MAA) to the European Medicines Agency (EMA)
for Cx601. TiGenix also recently announced 52-week data(5) indicating the
potential for efficacy and safety of a single treatment of Cx601 are maintained
during a year of follow up.
"We are very proud of the results of this study," said Prof. Dr. Julián Panés,
ADMIRE-CD Global Study Coordinator and Head of the Inflammatory Bowel Diseases
Unit at the Hospital Clínic of Barcelona. "The Lancet is one of the most highly
regarded and well known medical journals in the world; we are very delighted to
have the Cx601 data selected by this prestigious publication," he continued.
Dr. Marie Paule Richard, Chief Medical Officer at TiGenix stated that, "our
study is, to our knowledge, the first large-scale, randomized placebo-controlled
clinical trial to use clinical assessment of a fistula closure and MRI
assessment of absence of abscesses as recommended in the European Crohn's and
Colitis Organization guidelines.(6)"
Last month, TiGenix entered into a licensing agreement with Takeda, a global
leader in gastroenterology, under which Takeda acquired the exclusive right to
develop and commercialize Cx601 for complex perianal fistulas in Crohn's disease
outside the United States. Based on the data from this pivotal Phase 3 trial in
Europe, TiGenix submitted a marketing authorization application to the EMA in
the first quarter of 2016, and a decision by the EMA could be expected in 2017.
If granted, following Marketing Authorization in the European Economic Area
Takeda will become the Marketing Authorization holder and will be responsible
for all commercialization and regulatory activities.
A pivotal Phase 3 trial for Cx601 for the treatment of complex perianal fistulas
is expected to start in the United States in 2017. In the U.S., TiGenix intends
to apply for fast track designation from the U.S. Food and Drug Administration
(FDA), which would facilitate and expedite the development and review process in
the U.S.
About Takeda
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven
pharmaceutical company committed to bringing better health and a brighter future
to patients by translating science into life-changing medicines. Takeda focuses
its research efforts on oncology, gastroenterology and central nervous system
therapeutic areas. It also has specific development programs in specialty
cardiovascular diseases as well as late-stage candidates for vaccines. Takeda
conducts R&D both internally and with partners to stay at the leading edge of
innovation. New innovative products, especially in oncology, central nervous
system and gastroenterology, as well as its presence in emerging markets, fuel
the growth of Takeda. More than 30,000 Takeda employees are committed to
improving quality of life for patients, working with our partners in health care
in more than 70 countries. For more information,
visit http://www.takeda.com/news.
Takeda's Commitment to Gastroenterology
Takeda is a global leader in gastroenterology. With expertise spanning more than
25 years, the company's dedication to innovation continues to evolve and have a
lasting impact. ENTYVIO® (vedolizumab) demonstrates Takeda's global capabilities
and expansion into the specialty care market in gastroenterology and biologics.
Designed and developed specifically to target the gastrointestinal (GI) tract,
ENTYVIO was launched in 2014 for the treatment of adults with moderate to severe
ulcerative colitis and Crohn's disease. TAKECAB® (vonoprazan fumarate) is
Takeda's potassium-competitive acid blocker and was launched in Japan in
2015. Takeda also markets motility agent AMITIZA® (lubiprostone), which
originally launched in 2006 for the treatment of chronic idiopathic
constipation, and received subsequent approval to treat irritable bowel syndrome
with constipation and opioid-induced constipation. Preceding these notable
launches, Takeda pioneered gastroenterological breakthroughs in proton pump
inhibitors beginning in the 1990's with lansoprazole. Through specialized and
strategic in-house development, external partnerships, in-licensing and
acquisitions, Takeda currently has a number of promising early stage GI assets
in development, and remains committed to delivering innovative, therapeutic
options for patients with gastrointestinal and liver diseases.
About TiGenix
TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company
focused on developing and commercialising novel therapeutics from its
proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two
products from the adipose-derived stem cell technology platform are currently in
clinical development. Cx601 is in Phase III for the treatment of complex
perianal fistulas in Crohn's disease patients. Cx611 has completed a Phase I
sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective
July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product,
AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial
infarction (AMI). In addition, the second product candidate from the cardiac
stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being
developed in a chronic indication. On July 4, 2016, we entered into a licensing
agreement with Takeda, a large pharmaceutical company active in
gastroenterology, under which Takeda acquired the exclusive right to
commercialize Cx601 for complex perianal fistulas outside the United States.
TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid
(Spain). For more information, please visit http://www.tigenix.com/.
About Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
locally injected. Cx601 is an investigational agent being developed for the
treatment of complex perianal fistulas in Crohn's disease patients that failed
conventional therapy including antibiotics, immunosuppressant, or anti-TNF
therapy. Crohn's disease is a chronic inflammatory disease of the intestine and
patients can suffer from complex perianal fistulas for which there is currently
no effective treatment. In 2009, the European Commission granted Cx601 orphan
designation for the treatment of anal fistulas, recognizing the debilitating
nature of the disease and the lack of treatment options. Based on positive Phase
2 results, TiGenix sought scientific advice from the European Medicines Agency
(EMA) on the future development path of Cx601. TiGenix then initiated a
randomized, double-blind, placebo-controlled Phase 3 trial in Europe and Israel
designed to comply with the requirements laid down by the EMA. 'Madrid Network',
an organization within the Autonomous Region of Madrid which helps companies to
grow through high-technology innovation, issued a soft loan to help finance this
Phase 3 study. The program is funded by The Secretary of State for Research,
Development and Innovation (Ministry of Economy and Competitiveness) within the
framework of the INNTEGRA plan. The study's primary endpoint was combined
remission, defined as clinical assessment at week 24 of closure of all treated
external openings draining at baseline despite gentle finger compression, and
absence of collections >2cm confirmed by MRI. In the 24 weeks results of the
Phase 3 study reported in August 2015, Cx601 achieved statistically significant
superiority (p<0.025) on the primary endpoint with 49.5% combined remission at
week 24 compared to 34.3% in the placebo arm in the ITT population. These
results translate into a relative risk of 1.44, meaning that patients receiving
Cx601 had a 44% greater probability of achieving combined remission than placebo
patients. Efficacy results were robust and consistent across all statistical
populations. Treatment emergent adverse events (non-serious and serious) and
discontinuations due to adverse events were comparable between Cx601 and placebo
arms. The Phase 3 study trial has completed a follow-up analysis at 52 weeks
post-treatment. Based on the positive 24 weeks Phase 3 study results, TiGenix
has submitted a Marketing Authorization Application to the EMA in early 2016.
TiGenix is preparing to develop Cx601 in the U.S. after having reached an
agreement with the FDA through a special protocol assessment procedure (SPA) in
2015. On July 4, 2016 TiGenix entered into a licensing agreement with Takeda, a
pharmaceutical company leader in gastroenterology, whereby Takeda acquired an
exclusive right to commercialize Cx601 for complex perianal fistulas in Crohn's
patients outside of the U.S.
###
CONTACTS:
For TiGenix:
Claudia D'Augusta
Chief Financial Officer
claudia.daugusta(at)tigenix.com
+34 91 804 92 64
For Takeda:
Tsuyoshi Tada
Media in Japan
tsuyoshi.tada(at)takeda.com
+81 33 278 2417
Elissa Johnsen
Media outside of Japan
elissa.johnsen(at)takeda.com
+1 224 554 3185
References
(1. )Panés P, et al. Expanded allogeneic adipose-derived mesenchymal stem cells
(Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised,
double-blind controlled trial. The Lancet [online]. Published online July
28, 2016, available at http://dx.doi.org/10.1016/S0140-6736(16)31203-X.
(2. )Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy
for fistulizing Crohn's disease. N Engl J Med 2004; 350: 876-85. MRI stands for
Magnetic Resonance Imaging.
( 3. )Present DH, Rutgeerts P, Targan S, et al. Infliximab for the
treatment of fistulas in patients with Crohn's disease. N Engl J Med
1999; 340: 1398-405.
(4. )World IBD Day. Home. Published online July 28, 2016, available at
http://www.worldibdday.org/index.html.
(5. )TiGenix Press Release. TiGenix announces positive 52-week Phase III results
of Cx601 in complex perianal fistulas in Crohn's disease patients. Last accessed
July 29, 2016, available at http://bit.ly/2aA7DJr
(6. )Van Assche G, Dignass A, Reinisch W, et al. The second European evidence-
based consensus on the diagnosis and management of Crohn's disease: special
situations. J Crohns Colitis 2010; 4: 63-101.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: TiGenix via GlobeNewswire
[HUG#2032434]
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Datum: 02.08.2016 - 08:00 Uhr
Sprache: Deutsch
News-ID 486673
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