Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc.
(Nasdaq: KZR) announced today that the Center for Drug Evaluation
(CDE) of China’s National Medical Products Administration (NMPA)
approved Kezar’s investigational new drug (IND) application for
initiation of the Phase 2b PALIZADE trial in China of zetomipzomib
in patients with lupus nephritis (LN). Zetomipzomib is a novel,
first-in-class, selective immunoproteasome inhibitor with broad
therapeutic potential across multiple autoimmune diseases.
Everest will join Kezar and enroll patients in China as part of
the ongoing PALIZADE trial, a global, placebo-controlled Phase 2b
clinical trial evaluating the efficacy and safety of two dose
levels of zetomipzomib or placebo in patients with active LN. In
September 2023, Everest obtained exclusive rights to develop and
commercialize zetomipzomib in Greater China, South Korea and
Southeast Asia. LN is the most common secondary immune-mediated
glomerular disease, which may gradually lead to kidney failure.
There are an estimated 400,000-600,000 LN patients in China.
“With the approval of the zetomipzomib IND in China, Everest now
has three medicines in the renal space either commercialized or in
clinical development. We are excited about the initiation of this
clinical trial with the potential to benefit patients with LN
experiencing critical unmet medical needs," said Rogers Yongqing
Luo, Chief Executive Officer of Everest Medicines. “We intend to
leverage our expertise in clinical development, regulatory filings
and our newly established commercial infrastructure in China to
advance the development of zetomipzomib. We look forward to working
closely with Kezar on enrolling the PALIZADE trial and furthering
Everest’s leadership position in renal and autoimmune diseases in
Asia."
“This important milestone demonstrates that Everest is the ideal
regional partner for Kezar in our efforts to develop zetomipzomib,”
said Christopher Kirk, Ph.D., Chief Executive Officer of Kezar. “We
will continue to work with the outstanding team at Everest to help
drive enrollment in PALIZADE and get zetomipzomib to even more
patients in need in Asia.”
PALIZADE is a global, placebo-controlled, randomized,
double-blind Phase 2b clinical trial evaluating the efficacy and
safety of two dose levels of zetomipzomib in patients with active
LN. Target enrollment will be 279 patients, randomly assigned to
receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or placebo
subcutaneously once weekly for 52 weeks, in addition to standard
background therapy. Background therapy can, but will not be
mandated to, include standard induction therapy. Over the initial
16 weeks, there will be a mandatory corticosteroid taper to 5 mg
per day or less. End-of-treatment assessments will occur at Week
53. The primary efficacy endpoint is the proportion of patients who
achieve a complete renal response (CRR) at Week 37, including a
urine protein-to-creatine ratio (UPCR) of 0.5 or less without
receiving rescue or prohibited medications.
About Zetomipzomib
Zetomipzomib (KZR-616) is a novel, first-in-class, selective
immunoproteasome inhibitor with broad therapeutic potential across
multiple autoimmune diseases. Preclinical research demonstrates
that selective immunoproteasome inhibition results in a broad
anti-inflammatory response in animal models of several autoimmune
diseases, while avoiding immunosuppression. Data generated from
Phase 1 and Phase 2 clinical trials provide evidence that
zetomipzomib exhibits a favorable safety and tolerability profile
for development in severe, chronic autoimmune diseases.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on
discovering, developing, manufacturing and commercializing
transformative pharmaceutical products and vaccines that address
critical unmet medical needs for patients in Asian markets. The
management team of Everest Medicines has deep expertise and an
extensive track record from both leading global pharmaceutical
companies and local Chinese pharmaceutical companies in
high-quality discovery, clinical development, regulatory affairs,
CMC, business development and operations. Everest Medicines has
built a portfolio of potentially global first-in-class or
best-in-class molecules in the company’s core therapeutic areas of
renal diseases, infectious diseases and autoimmune disorders. For
more information, please visit its website at
www.everestmedicines.com.
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical
company developing novel treatments for immune-mediated and
oncologic disorders. Zetomipzomib, a selective immunoproteasome
inhibitor, is currently being evaluated in a Phase 2b clinical
trial for lupus nephritis and a Phase 2a clinical trial for
autoimmune hepatitis. This product candidate also has the potential
to address multiple chronic immune-mediated diseases. Kezar’s
oncology product candidate, KZR-261, targeting the Sec61 translocon
and protein secretion pathway, is being evaluated in an open-label
dose-escalation Phase 1 clinical trial to assess safety,
tolerability and preliminary tumor activity in solid tumors. For
more information, visit www.kezarlifesciences.com, and follow us on
LinkedIn, Facebook, Twitter and Instagram.
Forward-Looking Statements:
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “will,” “expects,” “anticipates,” “future,”
“intends,” “plans,” “believes,” “estimates,” “confident”,
“potential” and similar statements (as well as other words or
expressions referencing future events, conditions or circumstances)
are intended to identify forward-looking statements. These
forward-looking statements are based on the companies’ expectations
and assumptions as of the date of this press release.
Forward-looking statements contained in this press release include,
but are not limited to, statements about the clinical development
of zetomipzomib, the initiation, timing and enrollment of clinical
trials, the clinical development and therapeutic potential of
zetomipzomib, and the likelihood of obtaining regulatory approval
of zetomipzomib. Such forward-looking statements are not guarantees
of future performance and involve risks and uncertainties, or other
factors, some of which are beyond the control of the companies and
are unforeseeable. Therefore, the actual results may differ from
those in the forward-looking statements as a result of various
factors and assumptions, such as future changes and developments in
the companies’ business, competitive environment, regulatory
environment, political, economic, legal and social conditions.
Except as required by law, Everest and Kezar, as well as their
affiliates, directors, officers, advisors or representatives,
assume no obligation to update or revise forward-looking statements
to reflect new information, future events or circumstances, even as
new information becomes available.
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version on businesswire.com: https://www.businesswire.com/news/home/20240226328863/en/
Investor and Media Contact: Leah Liu Vice President,
Corporate Affairs Everest Medicines ir@everestmedicines.com
pr@everestmedicines.com
Gitanjali Jain Vice President, Investor Relations and External
Affairs Kezar Life Sciences, Inc. gjain@kezarbio.com
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