OSAKA, Japan & CAMBRIDGE, Mass. - Friday, 07. November 2025
−
Phase 1b, Open-Label Study Follow Up Shows Stable Kidney Function
(eGFR) in Patients Treated with Investigational Mezagitamab Through Week
96 – 18 Months After Last Dose1
− Rapid Reductions in Proteinuria and Serum Gd-IgA1 Levels Were Sustained Through Week 961
− No Serious Adverse Events or Opportunistic Infections Were Observed Through Week 961
−
Takeda Initiated Pivotal Phase 3 Clinical Trials Evaluating Mezagitamab
in Primary IgA Nephropathy and Immune Thrombocytopenia with Patient
Enrollment Ongoing
(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK)
today announced new interim data from the Phase 1b, open-label,
proof-of-concept study of subcutaneous mezagitamab (TAK-079), an
anti-CD38 monoclonal antibody with disease-modifying potential, in
primary immunoglobulin A (IgA) nephropathy. Data from the study showed
that kidney function (eGFR) remained stable in patients with IgA
nephropathy through Week 96 – up to 18 months after the last mezagitamab
dose.1 The results were presented at the American Society of Nephrology
(ASN) Kidney Week 2025 in Houston.
IgA nephropathy is a lifelong
progressive autoimmune disease often diagnosed in young people aged
10-30 years old that causes irreversible damage to the kidney function.2
It has no cure, and despite available treatments, approximately one in
five patients experience renal failure within 10 years of diagnosis.3 By
depleting cells that produce an abnormal protein called Gd-IgA1
implicated in the pathogenesis, mezagitamab targets early steps in the
process leading to disease in IgA nephropathy.
“Mezagitamab
targeted the underlying immune mechanisms of IgA nephropathy, with data
showing that kidney function remained stable in patients after the last
dose of treatment,” said Prof. Jonathan Barratt, M.D., Ph.D., principal
investigator for the Phase 1b study and the presenting author. “This is
especially critical given the progressive and often silent nature of the
disease, with many patients already experiencing some degree of kidney
damage by the time they’re diagnosed. Without effective intervention,
the risk of renal failure – and the need for dialysis or transplant –
remains alarmingly high.”
In the study, 17 patients with IgA
nephropathy were treated with mezagitamab as an add-on to stable
background therapy, and 13 patients continued into the long-term
follow-up period. At Week 96 – 18 months after the last dose – kidney
function remained stable (mean change in eGFR from baseline +2.5; 95%
CI: −1.8, +7.6; n=12) and patients sustained a 55.2% (95% CI: 30.2,
72.6; n=13) mean reduction in proteinuria (protein in the urine)
measured using a urine protein-creatinine ratio (UPCR).1 Sustained
reductions of 50.1% in Gd-IgA1 and complete recovery toward baseline in
IgG were observed by Week 96.1 Hematuria (blood in the urine) was
resolved in 60% of patients by Week 96.1
In this study,
mezagitamab was generally well tolerated with no new safety concerns
identified. No serious adverse events (AEs), including no serious
hypersensitivity or injection-related reactions, discontinuations due to
AEs, opportunistic infections or grade ≥3 infections were reported.1
“These
promising data reinforce our belief in the potential of mezagitamab to
redefine how autoimmune diseases like IgA nephropathy are treated – by
targeting their root cause,” said Obi Umeh, M.D., M.Sc., Vice President,
Franchise Global Program Leader at Takeda. “With patient enrollment
ongoing in our Phase 3 trials investigating mezagitamab in IgA
nephropathy and immune thrombocytopenia, we are excited to advance these
promising programs and remain committed to bringing innovative
solutions to patients with high unmet need.”
Mezagitamab is
currently in Phase 3 clinical development for the treatment of both
primary IgA nephropathy (NCT06963827) and chronic immune
thrombocytopenia (NCT06722235) with the first patients now enrolled. In
October 2025, mezagitamab was granted Orphan Drug Designation by the
European Medicines Agency for the treatment of primary IgA nephropathy.
In August 2025, mezagitamab was granted Breakthrough Therapy Designation
by the U.S. Food and Drug Administration for the treatment of adult
patients with chronic immune thrombocytopenia who have had an
insufficient response to previous treatment. Takeda is assessing
additional indications for mezagitamab.
About Mezagitamab
Mezagitamab
is a fully human, anti-CD38 IgG1 monoclonal antibody that depletes
cells that are high expressors of CD-38, such as plasma cells,
plasmablasts and natural killer cells. Depletion of these cells is
predicted to decrease formation of immune complexes, reduce inflammation
and thus the resulting proteinuria, ultimately preventing further
injury to the kidneys and promoting stabilization of kidney function
over time.
Mezagitamab is an investigational compound that has not been approved for use by any regulatory authority.
About the Mezagitamab Phase 1b Trial in IgA Nephropathy
The
Phase 1b trial, open-label, single-arm, multicenter study (NCT05174221)
evaluated mezagitamab as add-on to stable background therapy in
patients with primary immunoglobulin A (IgA) nephropathy.
Eligible
participants were adults with biopsy-proven disease and proteinuria
with urine protein-to-creatinine ratio (UPCR) ≥1 g/g from a 24-hour
urine collection or urine protein excretion ≥1g/24 hours and estimated
glomerular filtration rate (eGFR) ≥45 mL/min/1.73m.1 Participants
received subcutaneous mezagitamab 600 mg once weekly for 8 weeks, then
600 mg every two weeks for 16 weeks (16 total doses), followed by a
24-week safety follow-up.1 Participants with favorable proteinuria
response by Week 48 could enter the long-term follow up with a 48-week
observation period. The primary endpoint was the percentage of
participants with adverse events (AEs), including grade ≥3 AEs and
serious AEs, up to Week 96.1 Secondary and exploratory endpoints
included serum IgA, IgG and Gd-IgA1 levels, percentage change from
baseline in UPCR, change from baseline in eGFR and resolution of
hematuria (blood in urine).1
About Immunoglobulin A Nephropathy
Immunoglobulin
A (IgA) nephropathy is a lifelong progressive autoimmune disease often
diagnosed in young people aged 10-30 years old that causes irreversible
damage to the kidney function.2 It is caused by deposits of immune
complexes inside the filters in the kidney, which trigger inflammation
and damage to the kidney tissue, resulting in loss of renal function.2
There
is no cure for IgA nephropathy.3 It is associated with a poor prognosis
and can progress to kidney failure, which can lead to reduced quality
of life or premature death.1 Approximately one in five patients
experience renal failure within 10 years of diagnosis despite available
treatments.3
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.
Important Notice
For
the purposes of this notice, “press release” means this document, any
oral presentation, any question-and-answer session and any written or
oral material discussed or distributed by Takeda Pharmaceutical Company
Limited (“Takeda”) regarding this release. This press release (including
any oral briefing and any question-and-answer in connection with it) is
not intended to, and does not constitute, represent or form part of any
offer, invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any
securities or the solicitation of any vote or approval in any
jurisdiction. No shares or other securities are being offered to the
public by means of this press release. No offering of securities shall
be made in the United States except pursuant to registration under the
U.S. Securities Act of 1933, as amended, or an exemption therefrom. This
press release is being given (together with any further information
which may be provided to the recipient) on the condition that it is for
use by the recipient for information purposes only (and not for the
evaluation of any investment, acquisition, disposal or any other
transaction). Any failure to comply with these restrictions may
constitute a violation of applicable securities laws.
The
companies in which Takeda directly and indirectly owns investments are
separate entities. In this press release, “Takeda” is sometimes used for
convenience where references are made to Takeda and its subsidiaries in
general. Likewise, the words “we”, “us” and “our” are also used to
refer to subsidiaries in general or to those who work for them. These
expressions are also used where no useful purpose is served by
identifying the particular company or companies.
Forward-Looking Statements
This
press release and any materials distributed in connection with this
press release may contain forward-looking statements, beliefs or
opinions regarding Takeda’s future business, future position and results
of operations, including estimates, forecasts, targets and plans for
Takeda. Without limitation, forward-looking statements often include
words such as “targets”, “plans”, “believes”, “hopes”, “continues”,
“expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”,
“would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”,
“outlook” or similar expressions or the negative thereof. These
forward-looking statements are based on assumptions about many important
factors, including the following, which could cause actual results to
differ materially from those expressed or implied by the forward-looking
statements: the economic circumstances surrounding Takeda’s global
business, including general economic conditions in Japan and the United
States and with respect to international trade relations; competitive
pressures and developments; changes to applicable laws and regulations,
including tax, tariff and other trade-related rules; challenges inherent
in new product development, including uncertainty of clinical success
and decisions of regulatory authorities and the timing thereof;
uncertainty of commercial success for new and existing products;
manufacturing difficulties or delays; fluctuations in interest and
currency exchange rates; claims or concerns regarding the safety or
efficacy of marketed products or product candidates; the impact of
health crises, like the novel coronavirus pandemic; the success of our
environmental sustainability efforts, in enabling us to reduce our
greenhouse gas emissions or meet our other environmental goals; the
extent to which our efforts to increase efficiency, productivity or
cost-savings, such as the integration of digital technologies, including
artificial intelligence, in our business or other initiatives to
restructure our operations will lead to the expected benefits; and other
factors identified in Takeda’s most recent Annual Report on Form 20-F
and Takeda’s other reports filed with the U.S. Securities and Exchange
Commission, available on Takeda’s website at:
https://www.takeda.com/investors/sec-filings-and-security-reports/ or at
www.sec.gov. Takeda does not undertake to update any of the
forward-looking statements contained in this press release or any other
forward-looking statements it may make, except as required by law or
stock exchange rule. Past performance is not an indicator of future
results and the results or statements of Takeda in this press release
may not be indicative of, and are not an estimate, forecast, guarantee
or projection of Takeda’s future results.
Medical Information
This
press release contains information about products that may not be
available in all countries, or may be available under different
trademarks, for different indications, in different 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:
1.
Barratt J, Suzuki Y, et al. Safety, tolerability, and efficacy of
mezagitamab (TAK-079) as add-on to standard-of-care therapy in
individuals with primary IgA nephropathy: week 96 data from an
open-label phase 1b study. Poster FR-PO0808 presented at: American
Society of Nephrology (ASN) Kidney Week Annual Meeting; November 5-9,
2025; Houston, Texas, USA.
2. Cheung CK, Alexander S, et al. The
pathogenesis of IgA nephropathy and implications for treatment. Nature
Reviews Nephrology; 2024:1‐15.
3. IgA nephropathy. National
Institutes of Health.
https://www.niddk.nih.gov/health-information/kidney-disease/iga-nephropathy#what.
Accessed September 2025.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251107689017/en/
Permalink
https://www.aetoswire.com/en/news/0711202550698
Contacts
Media:
Japanese Media
Yuko Yoneyama
yuko.yoneyama@takeda.com
U.S. and International Media
Takeda Media Relations
media_relations@takeda.com
No comments:
Post a Comment