Patients receiving nine-dose regimen over five
months experienced deep and durable reduction in proteinuria,
reaching up to ~50% mean reduction in UPCR at end of study at month
24 and over 18 months after last dose
Patients across treatment arms exhibited
stabilization in eGFR through 24 months, while patients in placebo
arm showed a rapid decline in eGFR
Prolonged IgA reductions observed out to 24
months while IgG and IgM recovered to baseline shortly after last
dose, potentially enabling a sustained treatment benefit without
the need for chronic immunosuppression
SOUTH SAN FRANCISCO,
May 24,
2024 /PRNewswire/ -- Human Immunology Biosciences
(HI-Bio™), a clinical-stage biotechnology company developing
targeted therapies for patients with severe immune-mediated
diseases (IMDs), today announced positive interim results from the
randomized, placebo-controlled Phase 2 IGNAZ study of the
investigational CD38 antibody felzartamab in the treatment of IgA
nephropathy (IgAN).
Patients receiving a nine-dose regimen over five months
experienced a deep and durable decrease in proteinuria levels,
reaching up to ~50% mean reduction in UPCR at month 24, which was
more than 18 months after the last dose. In addition, patients
exhibited stabilization of kidney function as measured by eGFR
through 24 months. Administration of felzartamab was generally well
tolerated with a safety profile consistent with prior studies.
"Demonstrating a treatment effect that persists for more than 18
months after last dose of felzartamab represents a potential
departure from plasma- or B-cell-modulating agents that require
chronic dosing," commented Study Investigator and lead author
Jürgen Floege, M.D., RWTH Aachen University, Germany. "The reduction in proteinuria and
stabilization of eGFR we are seeing represent clinically meaningful
outcomes for patients with IgA nephropathy. The results also
suggest the potential for felzartamab in helping to preserve kidney
function while avoiding the need for chronic immunosuppression. In
addition, we are seeing selective and durable reductions in IgA
antibody levels with the recovery of IgG and IgM, which represents
a potential safety profile advantage for patients, as felzartamab
may allow maintenance of important immune functions that protect
against infection. The results of this study highlight
felzartamab's promise as a durable therapy and support its
continued investigation in IgA nephropathy."
"The results of the IGNAZ study are the first data investigating
the application of felzartamab in the treatment of IgA nephropathy
and the effects we have seen are highly encouraging," said
Uptal Patel, M.D., Chief Medical
Officer at HI-Bio. "Because felzartamab can selectively deplete
CD38+ plasma cells, upstream contributors to disease progression
and producers of Gd-IgA1 and anti-Gd-IgA1 antibodies, we believe
treatment with felzartamab may represent a potentially
disease-modifying approach that could help preserve kidney
function. We look forward to receiving final data from the IGNAZ
study later this year, which we expect to submit for presentation
in an appropriate peer-reviewed forum, and are evaluating next
steps in development for felzartamab in this indication."
Patients in the nine-dose group experienced a prolonged
pharmacodynamic effect of IgA reduction while IgG and IgM levels
showed recovery, with selective and durable reductions in IgA
levels maintained for more than 18 months following the last dose.
Felzartamab was generally well tolerated with no dose-dependent
adverse events and no exposure-safety relationship. Most adverse
events (AEs) were mild, and the most common type of AE was
infusion-related reactions (IRRs). There were two (5%) serious
adverse events in felzartamab-treated subjects (IRR, tendon
rupture) and infections were mostly mild and balanced across the
active treatment groups. Of the total number of patients treated
with felzartamab, five patients discontinued treatment due to IRRs
or hypersensitivity; for four of five patients, the infusion rate
was higher than protocol-specified or had an error in
pre-medication.
The Phase 2 IGNAZ study (NCT05065970) is a randomized,
placebo-controlled, multi-center, proof-of-concept and dose
evaluation study designed to assess safety and efficacy in adult
patients with high-risk IgAN. Patients were enrolled with
proteinuria (UPCR) of at least 1.0 g/d and eGFR of at least 30
ml/min/1.73 m2 and were
assigned to one of four groups receiving either placebo, two doses,
five doses or nine doses over a 24-week treatment phase of 16 mg/kg
of felzartamab provided by intravenous infusion. The study also
included an open-label treatment arm in Japan provided with the nine-dose schedule.
The study enrolled 54 patients in total and data were analyzed on a
per-protocol basis.
Data from the IGNAZ study were presented today at the
61st European Renal Association (ERA) Congress in
Stockholm. The full presentation
from the ERA Congress will be made available on HI-Bio's
website.
About IgA Nephropathy
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 Felzartamab
Felzartamab is an investigational therapeutic human monoclonal
antibody directed against CD38, a protein expressed on mature
plasma cells. 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. 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), where TJ Biopharma retains the
rights.
Felzartamab is an investigational therapeutic candidate that has
not yet been approved by any regulatory authority.
About HI-Bio
Human Immunology Biosciences, Inc. (HI-Bio™), was incubated by ARCH
Venture Partners and Monograph Capital to develop precision
therapies for immune-mediated diseases and to bring clinical
immunology into its next chapter. Inspired by the rise of targeted
therapies in clinical oncology, the company pursues a therapeutic
strategy of targeting and depleting the immune cell types that
drive IMDs. The company's most advanced candidate, felzartamab, is
a CD38-targeted antibody shown in clinical studies to deplete CD38+
cells, including plasma and natural killer (NK) cells, which are
implicated in a range of indications including antibody-mediated
rejection (AMR), IgA nephropathy (IgAN), lupus nephritis (LN) and
primary membranous nephropathy (PMN). Other investors include Alpha
Wave Global, Arkin Bio Capital, Jeito Capital and Viking Global
Investors.
To learn more about HI-Bio, visit www.hibio.com or
follow the company on LinkedIn and X.
References:
- Rajasekaran et al. (2021) IgA nephropathy: An interesting
autoimmune kidney disease. Available
at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8577278/. 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
Contact
|
|
Morgan Warners
|
Caroline
Fry
|
FGS Global
|
FGS
Global
|
morgan.warners@fgsglobal.com
|
caroline.fry@fgsglobal.com
|
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