Alofisel®▼ (darvadstrocel) Shows Clinical Remission Rate at Six-Months in the Real-World INSPIRE Study Interim Analysis Consistent with the Pivotal Clinical ADMIRE-CD Study1,2

  • Data on Patients with Complex Crohn’s Perianal Fistulas Were Presented at the European Crohn’s and Colitis Organisation (ECCO) 2022 Congress1
  • INSPIRE is the First Observational, Multicenter, Post-Approval, Open-Enrollment Study Designed to Evaluate the Real-World Effectiveness and Safety of Alofisel (darvadstrocel)1
  • Approved in the European Union/European Economic Area, Israel, Switzerland, United Kingdom and Japan, Alofisel, an Expanded Human Allogeneic Adipose-Derived Mesenchymal Stem Cell Therapy, Offers a Potential Cell-Mediated Closure Option for Patients with Complex Crohn’s Perianal Fistulas Who Have Shown an Inadequate Response to at Least One Conventional or Biologic Therapy3,4,5,6,7,8

Takeda (TSE:4502/NYSE:TAK) today announced the first six-month interim analysis results from INSPIRE, in which clinical remission* was observed in 65% of patients in both cohorts who were evaluated at 6 months.1 INSPIRE is a European, observational, multicenter, post-approval, open-enrollment study (EUPAS24267) evaluating the real-world effectiveness and safety of Alofisel (darvadstrocel) in patients with Crohn’s disease (CD) and complex perianal fistulas.1,2

As of September 2021, 230 patients had enrolled in the ongoing study.1 The All Treated (AT) cohort consisted of all patients in the study who received Alofisel; the Treated Per Protocol (PP) cohort consisted of all patients in the study who received Alofisel according to protocol recommendation.1 138 patients in the All Treated (AT) cohort and 120 patients in the Treated Per Protocol (PP) cohort were six-months post treatment and 66% for AT (92/138) and 58% for PP (69/120) had a six-month visit completed.1 Among them, 85% (78/92) of the AT cohort and 100% (69/69) of the PP cohort had clinical outcome data available at six-months.1 Clinical response†, was observed in 73% (57/78) and 74% (51/69) of patients in the AT and PP cohorts, respectively.1 Clinical remission* was observed in 65% of patients in both cohorts (AT cohort: 51/78; PP cohort: 45/69).1

“Complex perianal fistulas are a painful, disabling and often embarrassing complication of Crohn’s disease that can be extremely challenging to treat.9,10,11,12 Despite advances, many patients relapse and do not achieve fistula closure following treatment,13” said Professor Oded Zmora, Colon and Rectal Surgeon and Chair of the Department of Surgery, Shamir Medical Center, Tel Aviv, Israel, and Chair of the INSPIRE steering committee. “These promising initial results from the INSPIRE study build knowledge on Alofisel as a treatment option in this area, and I look forward to future analyses with longer follow-up times.”

“We are delighted to present the results of the first interim analysis from the real-world multicenter INSPIRE study. These results are consistent with the pivotal Phase 3 ADMIRE-CD study in terms of efficacy and safety,1” said Elisabeth Genestin, Senior Global Brand Medical Affairs Director GI Rare Disease, Takeda. “The INSPIRE study aims to include more patients, to promote a better understanding of disease presentation, patient characteristics, patterns of care and clinical outcomes in a large multicenter, heterogenous patient population and we look forward to sharing more data and insights with the community as the study progresses.2

About Alofisel
Alofisel is a suspension of expanded allogeneic (donor-derived), adipose-derived mesenchymal stem cells (eASC) for the treatment of complex perianal fistulas in adult patients with non-active or mildly active luminal CD.3 In March 2018, Alofisel became the first allogeneic stem cell therapy to receive central marketing authorization approval in the European Union.3,14 In 2019, darvadstrocel received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for complex perianal fistulas in adult patients with CD.15 In September 2021, Alofisel became the first expanded human allogeneic adipose-derived mesenchymal stem cell therapy to be approved in Japan.4,16

Therapeutic Indications
Alofisel is approved in the European Union/European Economic Area, Israel, Switzerland and the United Kingdom for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.3,5,6 Alofisel should be used only after conditioning of the fistulas.3,5,6

In Japan, Alofisel is indicated for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease (CD).4,16 This product is indicated for the treatment of patients who have shown an inadequate response to at least one existing medicinal treatment.4,16
Takeda in Gastroenterology
We believe that gastrointestinal (GI) and liver diseases are not just life-disrupting conditions, but diseases that can impact a patient’s quality of life.17,18 Beyond a fundamental need for effective treatment options, we understand that improving patients’ lives also depends on their needs being recognized.17,18 With nearly 30 years of experience in gastroenterology, Takeda has made significant strides in addressing GI patient needs with treatments for inflammatory bowel disease (IBD), acid-related diseases, short bowel syndrome (SBS), and motility disorders. We are making significant strides toward closing the gap on new areas of unmet needs for patients who have celiac disease, alpha-1 antitrypsin-associated liver disease and Crohn’s disease, among others. Together with researchers, patient groups and more, we are working to advance scientific research and clinical medicine in GI.

About Takeda
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

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