- Mezagitamab-Treated Patients Showed Rapid and Sustained
Increases in Platelet Counts That Persisted 8 Weeks After the Last
Dose Through to Week 161
- Mezagitamab Had a Favorable Safety Profile, with No New
Safety Signals1
- Takeda Plans to Initiate Global Phase 3 Trial of Mezagitamab
in ITP in the Second Half of FY2024
Takeda (TSE:4502/NYSE:TAK) today presented positive results from
its Phase 2b, 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), a rare immune-mediated bleeding disorder.
ITP is characterized by the accelerated destruction of platelets in
blood, resulting in a decreased platelet count and an increase of
bleeding that can be debilitating. These data (Abstract #LB 01.1)
were presented at the oral Late-Breakthrough Session at the 32nd
Congress of the International Society on Thrombosis and Haemostasis
(ISTH) in Bangkok, Thailand. Takeda plans to initiate a global
Phase 3 trial of mezagitamab in patients with ITP in the second
half of FY2024.
The TAK-079-1004 trial (NCT04278924) evaluated three different
doses of subcutaneous mezagitamab (100mg, 300mg and 600mg) versus
placebo, given once weekly for eight weeks in patients with chronic
or persistent primary ITP, followed by >8 weeks of safety follow-up. The primary
endpoint is the percentage of patients with at least one Grade 3 or
higher treatment emergent adverse events (TEAEs), serious adverse
events (SAEs), and adverse events (AEs) leading to mezagitamab
discontinuation.2 Secondary endpoints included platelet response,
complete platelet response, clinically meaningful platelet
response, and hemostatic platelet response.1,2
The Phase 2b trial results demonstrated that mezagitamab
treatment improved platelet response compared to placebo, across
all three dose levels of mezagitamab tested. Patients treated with
mezagitamab showed rapid and sustained increases in platelet counts
(above the 50,000/μL therapeutic threshold)4, that persisted eight
weeks after the last dose through to Week 16, illustrating the
rapid and post-therapy effects of mezagitamab on platelet
response.1
- All the different measures of platelet response evaluated were
highest among patients treated with the mezagitamab 600mg dose,
specifically 81.8% achieved complete platelet response, 90.9%
clinically meaningful platelet response, and 100% hemostatic
platelet response.1
- Fewer mezagitamab-treated patients compared to placebo had ≥1
disease activity-related bleeding AE (17.9% vs 46.2%,
respectively).1
“Despite treatment with currently available therapies, there is
still a significant disease burden and need for a disease modifying
treatment that people living with ITP can tolerate,” said David
Kuter, M.D., D.Phil., a leading expert in ITP and study presenter
at the ISTH oral Late-Breakthrough Session. “These Phase 2b trial
results are especially encouraging because they show mezagitamab’s
favorable efficacy and safety profile – setting the stage for the
generation of additional clinical evidence for this anti-CD38
monoclonal antibody with best-in-class potential for efficacy in
ITP.”
In this study, mezagitamab had a favorable safety profile in
patients with ITP, with no new safety signals and consistent with
prior studies of mezagitamab.1 The rates of TEAEs leading to
discontinuation, Grade >3 TEAEs,
and SAEs, between the mezagitamab dose groups combined versus
placebo were 14.3% versus 0%, 17.9% versus 23.1%, and 14.3% versus
7.7% respectively.1
“It is a privilege to have these Phase 2b mezagitamab results
selected for presentation as a late-breaking abstract at the ISTH
Congress,” said Obi Umeh, M.D., M.Sc., Vice President, Franchise
Global Program Leader at Takeda. “Based on these results, we plan
to initiate a Phase 3 study of mezagitamab in ITP in the second
half of FY2024, further underscoring our goal to develop
transformative treatments in therapeutic areas with high unmet
patient needs.”
About Mezagitamab
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. Therapy with mezagitamab is designed
to deliver rapid and sustained improvement in platelet response and
to restore platelet counts to functional levels.
Mezagitamab previously received Orphan Drug Designation for the
treatment of ITP and Fast Track Designation for treatment of
chronic/persistent ITP from the U.S. Food and Drug Administration.
Mezagitamab is an investigational compound that has not been
approved for use by any regulatory authority.
About the Mezagitamab Phase 2b Trial in ITP
The data presented at the ISTH oral Late-Breakthrough Session
are from a pre-specified interim analysis of the Phase 2b trial, a
randomized, double-blind, placebo-controlled study evaluating the
safety, tolerability, and efficacy of mezagitamab in patients with
persistent or chronic primary ITP. The trial had two parts: 25
participants were randomized (1:1:1) to mezagitamab 100mg or 300mg,
or placebo in Part A while 16 participants were randomized (2:1) to
mezagitamab 600mg or placebo in Part B. Participants received once
weekly subcutaneous mezagitamab or placebo for 8 doses, followed by
≥8 weeks of safety follow-up.1
The primary endpoint is the percentage of patients with TEAEs
including Grade 3 or higher events, SAEs and AEs leading to
mezagitamab discontinuation. Secondary efficacy endpoints include
and are defined as: platelet response (a platelet count ≥50,000/μL
and ≥20,000/μL above baseline); complete platelet response (a
platelet count ≥100,000/μL); clinically meaningful platelet
response (a platelet count ≥20,000/μL above baseline); and
hemostatic platelet response (participants with a baseline platelet
count of <15,000/μL who achieve a platelet count of ≥30,000/μL
and ≥20,000/μL above baseline).2 For all secondary efficacy
endpoints, platelet counts must be achieved on at least two visits
without a dosing period-permitted rescue treatment in the previous
four weeks and without any other previous rescue therapy.2
About ITP
ITP is a rare, IgG mediated autoimmune disease caused, in part,
by the development of autoantibodies to platelets (and/or
megakaryocytes), which are blood components responsible for
preventing or stopping bleeding. It 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.3,4
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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or at https://www.sec.gov/. Takeda does not undertake to update any
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Medical Information
This press release contains information about products that may
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dosages, or in different strengths. Nothing contained herein should
be considered a solicitation, promotion or advertisement for any
prescription drugs including the ones under development.
References:
- Kuter D, Pulanic D, et al. Safety, tolerability, and efficacy
of mezagitamab (TAK-079) in chronic or persistent primary immune
thrombocytopenia: Interim results from a phase 2, randomized,
double-blind, placebo-controlled study. In: International Society
on Thrombosis and Haemostasis (ISTH) Congress; June 22-26, 2024;
Bangkok, Thailand. Abstract LB 01.1.
- https://clinicaltrials.gov/study/NCT04278924. Accessed June
2024.
- 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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version on businesswire.com: https://www.businesswire.com/news/home/20240622463950/en/
Japanese Media Yuko Yoneyama yuko.yoneyama@takeda.com
U.S. and International Media Mark Dole
mark.dole@takeda.com
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