− Pre-Specified Interim Analysis Shows Positive Safety and
Efficacy Results; Mezagitamab Safe and Well Tolerated
− Takeda Intends to Initiate a Global Phase 3 Trial of
Mezagitamab in Patients with Primary Immune Thrombocytopenia in
Fiscal Year 2024
− Late-Stage Pipeline Continues to Gain Momentum With Five
New Molecular Entities in Phase 3 Development in Fiscal Year
2024
Takeda (TSE:4502/NYSE:TAK) today announced
positive topline results from a Phase 2, randomized, double-blind,
placebo-controlled study evaluating the safety, tolerability and
efficacy of mezagitamab (TAK-079) in patients with persistent or
chronic primary immune thrombocytopenia (ITP). Mezagitamab is a
fully human immunoglobulin IgG1 monoclonal antibody (mAb) with high
affinity for CD38 expressing cells (including plasmablasts, plasma
cells, natural killer cells) resulting in their depletion.
The TAK-079-1004 trial (NCT04278924) evaluated three different
doses of subcutaneous mezagitamab vs placebo, given once weekly for
eight weeks in patients with chronic (more than one year in
duration) or persistent (3-12 months in duration) primary ITP. An
interim analysis of the ongoing Phase 2 study demonstrated positive
safety and efficacy results. Mezagitamab has been generally safe
and well tolerated across all three cohorts. All mezagitamab doses
tested demonstrated a higher platelet response rate than placebo.
The increases in platelet count were dose-dependent with the
greatest platelet response observed at the highest dose tested.
Platelet response in mezagitamab treated patients occurred rapidly
and was maintained post-therapy.
Based on these positive results, and following consultation with
global health authorities, Takeda plans to initiate a global Phase
3 trial of mezagitamab in ITP in fiscal year 2024. When mezagitamab
advances to Phase 3 in ITP Takeda will have five new molecular
entities in Phase 3 development in fiscal year 2024 including
TAK-279 for the treatment of psoriasis and psoriatic arthritis,
TAK-861 for the treatment of narcolepsy type 1, soticlestat for the
treatment of Lennox-Gastaut syndrome and Dravet syndrome, and
fazirsiran for the treatment of α1-antitrypsin associated liver
disease.
ITP is a rare, IgG mediated autoimmune disease caused, in part,
by the development of autoantibodies to platelets (and/or
megakaryocytes), which are blood cells responsible for preventing
or stopping bleeding. ITP is characterized by the accelerated
destruction of platelets (with or without impaired production),
resulting in a decreased platelet count and an increased risk of
bleeding, which can be debilitating (including fatigue and impaired
quality of life), and in severe cases may be life-threatening. The
precedent for approval of new drugs in this indication requires
that platelet counts be maintained at 50,000/uL or more for a
sustained period. Approximately 20 percent of patients with ITP do
not achieve a platelet count above 50,000/uL following treatment
with available first- and second-line therapies creating
significant patient burden and unmet need for a disease modifying
treatment that is also tolerable.1,2
“These Phase 2 results demonstrate mezagitamab’s compelling
disease modifying mechanism of action, which has the potential to
achieve disease remission for people with ITP. There remains
considerable unmet need among ITP patients who may not respond or
have inadequate response to prior treatment. In addition, some
patients who do respond to available therapies struggle to manage
side effects or relapse despite treatment,” said Chinwe Ukomadu,
Head of the Gastrointestinal & Inflammation Therapeutic Area
Unit at Takeda. “We look forward to initiating the Phase 3 trial
and presenting these data at an upcoming scientific congress.”
Therapy with mezagitamab is designed to deliver rapid and
sustained improvement in platelet response and generally rapidly
restores platelet counts to functional levels. Mezagitamab
previously received Orphan Drug Designation for the treatment of
ITP from the U.S. Food and Drug Administration and the program
recently received Fast Track Designation.
Results from the Phase 2 trial have no impact on the full year
consolidated reported forecast for the fiscal year ending March 31,
2024 (Fiscal Year 2023).
About Takeda
Takeda is focused on creating better health for people and a
brighter future for the world. We aim to discover and deliver
life-transforming treatments in our core therapeutic and business
areas, including gastrointestinal and inflammation, rare diseases,
plasma-derived therapies, oncology, neuroscience, and vaccines.
Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
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References
- Provan D, Donald A, et al. Blood Advances.
2019;26;3(22):3780-3817.
- Rodeghiero F. International Journal of Hematology.
2023;117:316–33.
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Media Contacts: Japanese Media Yuko
Yoneyama yuko.yoneyama@takeda.com +81
70-2610-6609 U.S. and International Media Chris
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Takeda Pharmaceutical (NYSE:TAK)
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