Biogen Presents Positive Results from Phase 2 IGNAZ Study of Felzartamab in IgA Nephropathy at American Society of Nephrology (ASN) Kidney Week 2024
October 26 2024 - 8:15PM
UK Regulatory
Biogen Presents Positive Results from Phase 2 IGNAZ Study of
Felzartamab in IgA Nephropathy at American Society of Nephrology
(ASN) Kidney Week 2024
- The detailed study results confirmed interim findings, showing
stable kidney function and sustained treatment effect more than 18
months after the last dose of felzartamab
- Felzartamab, an investigational anti-CD38 monoclonal antibody,
is a potential first-in-class therapeutic candidate for a range of
rare immune-mediated indications with planning underway for Phase 3
development
- IgA Nephropathy (IgAN) is a leading cause of chronic kidney
disease with up to 40% of IgAN patients progressing to end stage
kidney disease about 20 years after diagnosis
CAMBRIDGE, Mass., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Biogen Inc.
(Nasdaq: BIIB) – today presented complete results from the Phase 2
IGNAZ study evaluating felzartamab, an investigational anti-CD38
monoclonal antibody, in people living with IgA nephropathy (IgAN).
The results showed substantial reductions in proteinuria,
stabilization of kidney function, and sustained treatment effect
more than 18 months after the last dose of felzartamab. The
complete results were shared during an oral presentation at Kidney
Week 2024, the American Society of Nephrology’s annual meeting, in
San Diego, California.
"The complete results of the IGNAZ Study reaffirm our interim
findings, showing a reduction in proteinuria, stabilization of
kidney function, and sustained treatment effect more than 18 months
after the last dose of felzartamab,” said Jonathan Barratt, MD,
PhD, FRCP, Mayer Professor of Renal Medicine at the University of
Leicester. “This is promising news for patients and supports the
potential of felzartamab to be a meaningful treatment option for
people living with IgA nephropathy, a leading cause of chronic
kidney disease.”
The Phase 2 IGNAZ study (n=54) explored the efficacy and safety
of felzartamab in patients with IgAN and high risk of progressive
kidney dysfunction. With respect to efficacy, patients receiving a
nine-dose regimen of felzartamab over a six-month treatment period
experienced substantial reductions in proteinuria levels as
assessed by the urinary protein:creatinine ratio (UPCR) and
stabilization of kidney function, as measured by the estimated
glomerular filtration rate (eGFR), through 24 months. Notably,
patients maintained a mean reduction of approximately 50% in the
UPCR through month 24, which was more than 18 months after the last
dose was administered. These results suggest that felzartamab may
have the potential to preserve kidney function and be administered
on treatment cycles instead of continuous dosing.
Further analysis revealed that felzartamab administration
resulted in selective and durable reductions in IgA antibody
levels, while IgG and IgM levels recovered to baseline 3 months
off-treatment. This selective reduction may offer maintenance of
significant immune functions essential for infection protection.
Overall, administration of felzartamab was generally well tolerated
with a safety profile consistent with prior studies.
“We are encouraged by the overall results of the IGNAZ study,
especially given the significant unmet medical need for additional
treatments to address high-risk IgA nephropathy,” said Uptal Patel,
M.D., Head of Development, HI-Bio at Biogen. “We are grateful to
all the participants, investigators and study staff who contributed
to this study, whose findings will help us continue to evaluate
felzartamab’s role in preserving kidney function as we plan for
Phase 3.”
About Felzartamab
Felzartamab is an investigational therapeutic human monoclonal
antibody directed against CD38, a protein expressed on mature
plasma cells. Felzartamab is a potential first-in-class therapeutic
candidate with promise as a pipeline-in-a-product across a range of
immune-mediated diseases. Felzartamab has been shown in clinical
studies to selectively deplete CD38+ plasma cells, which may allow
applications that ultimately improve clinical outcomes in a broad
range of diseases driven by pathogenic antibodies. Felzartamab was
originally developed by MorphoSys AG for multiple myeloma. Human
Immunology Biosciences (HI-Bio) exclusively licensed the rights to
develop and commercialize felzartamab across all indications in all
countries and territories excluding China (including Macau and Hong
Kong and Taiwan). Biogen acquired HI-Bio in July 2024.
Felzartamab is an investigational therapeutic candidate that has
not yet been approved by any regulatory authority and its safety
and effectiveness have not been established.
About IgA Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is the most common primary
glomerulonephritis worldwide. It is a leading cause of chronic
kidney disease with up to 40% of IgAN patients progressing to end
stage kidney disease about 20 years after diagnosis. IgAN accounts
for about 40% of all native-kidney biopsies in Japan, 25% in
Europe, 12% in the United States, but less than 5% in central
Africa.1
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that
pioneers innovative science to deliver new medicines to transform
patients’ lives and to create value for shareholders and our
communities. We apply deep understanding of human biology and
leverage different modalities to advance first-in-class treatments
or therapies that deliver superior outcomes. Our approach is to
take bold risks, balanced with return on investment to deliver
long-term growth.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social
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Biogen Safe Harbor
This news release contains forward-looking statements, including
related to the potential clinical effects of felzartamab; the
potential benefits, safety and efficacy of felzartamab; the
clinical development program for felzartamab; the identification
and treatment of IgAN; our research and development program for the
treatment of IgAN; the potential of our commercial business and
pipeline programs, including felzartamab; and risks and
uncertainties associated with drug development and
commercialization. These forward-looking statements may be
accompanied by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“potential,” “possible,” “will,” “would” and other words and terms
of similar meaning. Drug development and commercialization involve
a high degree of risk, and only a small number of research and
development programs result in commercialization of a product.
Results in early-stage clinical trials may not be indicative of
full results or results from later stage or larger scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on our forward-looking statements.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation, uncertainty of
success in the development and potential commercialization of
including felzartamab; the risk that we may not fully enroll our
clinical trials or enrollment will take longer than expected;
unexpected concerns may arise from additional data, analysis or
results obtained during our clinical trials; regulatory authorities
may require additional information or further studies, or may fail
or refuse to approve or may delay approval of our drug candidates,
including felzartamab; the occurrence of adverse safety events; the
risks of unexpected hurdles, costs or delays; failure to protect
and enforce our data, intellectual property and other proprietary
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and challenges; product liability claims; results of operations and
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consider this cautionary statement, as well as the risk factors
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Commission. These statements speak only as of the date of this news
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We do not undertake any obligation to publicly update any
forward-looking statements.
References:
- Rajasekaran et al. (2021) IgA
nephropathy: An interesting autoimmune kidney disease. Available at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198292/. Hastings et
al (2018) Clinical Research, Life Expectancy for Patients From the
Southeastern United States With IgA Nephropathy. Available at
https://www.kireports.org/article/S2468-0249(17)30362-5/fulltext
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