Kezar Life Sciences Receives FDA Clearance of IND for Zetomipzomib for the Treatment of Autoimmune Hepatitis
October 03 2022 - 4:01PM
Business Wire
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Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage
biotechnology company discovering and developing breakthrough
treatments for immune-mediated and oncologic disorders, today
announced that it has received clearance of its Investigational New
Drug (IND) application from the U.S. Food and Drug Administration
for zetomipzomib, its first-in-class, selective immunoproteasome
inhibitor, for the treatment of autoimmune hepatitis (AIH).
AIH is a rare, chronic disease in which the immune system
attacks the liver and causes inflammation and tissue damage,
severely impacting patients’ physical health and quality of life.
Lifelong maintenance therapy is required to avoid relapse and
burdensome adverse effects. If left untreated, AIH can lead to
cirrhosis, liver failure and hepatocellular carcinoma. In the
United States, AIH affects approximately 140,000 individuals, with
incidence rates increasing. The cause of this condition remains
unclear. Females are affected four times as often as males.
Standard of care treatment for AIH is immunosuppressive treatment
with chronic corticosteroids that can lead to additional morbidity
and mortality. There is a significant need for treatment regimens
that reduce or remove the need for chronic immunosuppression using
corticosteroids.
The PORTOLA trial (KZR-616-208) is a randomized, double-blind,
placebo-controlled Phase 2a clinical trial evaluating the safety
and efficacy of zetomipzomib in patients with AIH that are
insufficiently responding to standard of care or have relapsed. The
target enrollment will be 24 patients, who will be randomly
assigned (2:1) to receive either zetomipzomib with prednisone or
placebo with prednisone for 24 weeks, with a protocol-directed
steroid taper by Week 14. The primary efficacy endpoint will
measure the proportion of patients who achieve a complete response
measured as normalization of alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) levels with a successful
corticosteroid taper by Week 24.
“Zetomipzomib is a unique small molecule with the potential to
be a non-immunosuppressive, anti-inflammatory treatment for
multiple autoimmune diseases. We plan to run PORTOLA, an early
proof-of-concept study in parallel to our other development
efforts, including a late-phase efficacy trial for patients with
lupus nephritis and a potential program in patients with systemic
lupus erythematosus,” said Noreen R. Henig, M.D., Kezar’s Chief
Medical Officer. “Autoimmune hepatitis is a disease where there is
a good fit between the pathophysiology of the disease and mechanism
of action of zetomipzomib, as well as significant unmet medical
need and few alternative therapies. We are grateful to the
Autoimmune Hepatitis Association for their support of the patients
and families with AIH and their connection to dedicated physicians
and researchers in autoimmune liver disease.”
“Patients with autoimmune hepatitis need new therapies that can
better treat their disease. Lifelong maintenance therapy is
required for most patients with AIH and an alternative regimen that
reduces or removes the need for immunosuppression with
corticosteroids would be welcomed by patients and the medical
community,” commented Craig Lammert, M.D., Assistant Professor of
Medicine at Indiana University and Executive Director of the
Autoimmune Hepatitis Association.
About Zetomipzomib (KZR-616)
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 clinical trials provide evidence that zetomipzomib exhibits
a favorable safety and tolerability profile for development in
severe, chronic autoimmune diseases.
About Autoimmune Hepatitis
Autoimmune Hepatitis (AIH) is a rare chronic disease in which
the immune system attacks the liver and causes inflammation and
tissue damage, severely impacting patients’ physical health and
quality of life. Lifelong maintenance therapy is required to avoid
relapse and burdensome adverse effects. If left untreated, AIH can
lead to cirrhosis, liver failure and hepatocellular carcinoma. In
the United States, AIH affects approximately 140,000 individuals,
with incidence rates increasing. The cause of this condition
remains unclear, with females affected four times as often as
males. Currently, standard of care treatment for AIH is chronic,
immunosuppressive treatment with corticosteroids that frequently
cause life-altering side effects, including diabetes, osteoporotic
fractures and cataracts. There is a significant need for treatment
regimens that reduce or remove the need for chronic
immunosuppression using corticosteroids.
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical
company discovering and developing breakthrough treatments for
immune-mediated and oncologic disorders. The company is pioneering
first-in-class, small-molecule therapies that harness master
regulators of cellular function to inhibit multiple drivers of
disease via single, powerful targets. Zetomipzomib, its lead
development asset, is a selective immunoproteasome inhibitor being
evaluated in Phase 2 clinical trials in lupus nephritis,
dermatomyositis and polymyositis. This product candidate also has
the potential to address multiple chronic immune-mediated diseases.
KZR-261 is the first anti-cancer clinical candidate from the
company’s platform targeting the Sec61 translocon and the protein
secretion pathway. An open-label dose-escalation Phase 1 clinical
trial of KZR-261 to assess safety, tolerability and preliminary
tumor activity in solid tumors is underway. For more information,
visit www.kezarlifesciences.com.
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “may,” “will,” “should,” “expect,” “believe”,
“plan” and similar expressions (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 Kezar’s expectations and
assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties that
could cause Kezar’s clinical development programs, future results
or performance to differ materially from those expressed or implied
by the forward-looking statements. Forward-looking statements
contained in this press release include, but are not limited to,
statements about the design, progress, timing, scope and results of
clinical trials, the anticipated regulatory development and future
clinical trials involving Kezar’s product candidates, the
likelihood that data will support future development and
therapeutic potential, the association of data with treatment
outcomes and the likelihood of obtaining regulatory approval of
Kezar’s product candidates. Many factors may cause differences
between current expectations and actual results, including
unexpected safety or efficacy data observed during clinical
studies, changes in expected or existing competition, the
uncertainties and timing of the regulatory approval process and
unexpected litigation or other disputes. Other factors that may
cause actual results to differ from those expressed or implied in
the forward-looking statements in this press release are discussed
in Kezar’s filings with the U.S. Securities and Exchange
Commission, including the “Risk Factors” contained therein. Except
as required by law, Kezar assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
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version on businesswire.com: https://www.businesswire.com/news/home/20221003006001/en/
Investor Contact: Gitanjali Jain Vice President, Investor
Relations and External Affairs gjain@kezarbio.com Media
Contact: Julia Deutsch Solebury Strategic Communications
jdeutsch@soleburystrat.com
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