Kezar Highlights Broad Therapeutic Potential of KZR-616 During ACR Convergence 2020
November 05 2020 - 8:46AM
Business Wire
Clinical and
pre-clinical data continues to support potential of KZR-616 to
positively effect multiple drivers of immune-mediated diseases
Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage
biotechnology company discovering and developing breakthrough
treatments for immune-mediated and oncologic disorders, today
highlighted the broad therapeutic potential of KZR-616, a
first-in-class immunoproteasome inhibitor, in two poster sessions
during the American College of Rheumatology Annual Meeting (ACR
Convergence 2020). Both posters can be found on Kezar’s website
under the “Science” section.
Richard Furie, M.D., Chief, Division of Rheumatology, Northwell
Health in New York, is presenting updated results from the MISSION
Phase 1b study (NCT03393013) evaluating KZR-616 in patients with
systemic lupus erythematosus (SLE) with and without lupus nephritis
(LN). The presentation by Dr. Furie includes additional
patient-weeks of safety and tolerability data compared to prior
data presentations. Encouraging trends in early efficacy signals
continue, including improvement of SLE-specific disease activity
scores. No new safety signals have been observed, and KZR-616
administered subcutaneously (SC) once weekly has been consistently
well tolerated for 13 weeks. KZR-616 has been studied at doses of
45 mg, 60 mg and 75 mg SC weekly. Previously, Kezar has identified
45 mg and 60 mg as likely therapeutic doses to advance in its
clinical development program.
Kezar’s collaborator, Marta Del Rio Oliva, Ph.D. candidate of
the University of Konstanz, is presenting an evaluation of KZR-616
in a well-accepted preclinical mouse model of inflammatory
myositis. In this model of myositis, KZR-616 treatment was
associated with significant improvement in muscle function and
reduced levels of muscle tissue damage. It is also demonstrated
that an active immunoproteasome is necessary for the disease to
occur. These data suggest that selective inhibition of the
immunoproteasome with KZR-616 could have a meaningful clinical
impact in patients with inflammatory myopathies, such as
dermatomyositis (DM) and polymyositis (PM). Kezar is actively
enrolling the PRESIDIO Phase 2 study (NCT04033926), a
placebo-controlled, cross-over study of patients with DM and PM.
The open-label extension study for PRESIDIO is also enrolling.
“These two presentations strengthen our understanding of how
KZR-616 can be an effective treatment for patients with a variety
of autoimmune diseases. The preclinical data show the importance of
the immunoproteasome in the pathology of myositis and the ability
of KZR-616 to selectively inhibit this important regulator of
immune function for therapeutic benefit. The clinical data
continues to show that KZR-616 is well- tolerated and improves
multiple signs and symptoms of SLE. We continue to build a strong
foundation for KZR-616 as a novel and important therapeutic for
patients living with LN, dermatomyositis and polymyositis and other
immune-mediated diseases,” said Noreen Henig, M.D., Kezar’s Chief
Medical Officer.
About MISSION
MISSION (NCT03393013) is a Phase 1b/2 clinical trial evaluating
KZR-616 in SLE patients with and without nephritis. The study
consists of two parts. The Phase 1b portion is an open-label dose
escalation study which is evaluating doses up to 75 mg of KZR-616
across 6 cohorts, which has completed enrollment. The primary
objective of the Ph1b portion of MISSION is to assess safety and
tolerability. Secondary objectives include evaluating
pharmacokinetics (PK) and pharmacodynamics (PD) and selecting dose
levels for the Phase 2 trials. Several exploratory efficacy
measures are also being assessed: Systemic Lupus Erythematosus
Disease Activity Index 2000 (SLEDAI-2K), Cutaneous Lupus
Erythematosus Severity Index-Activity (CLASI-A), Tender and Swollen
Joint Counts (TJC/SJC), Physician Global Assessment (PhGA), Patient
Global Assessment (PtGA) and Patient Assessment of Pain (PtP). The
Phase 2 portion of the MISSION study evaluating KZR-616 in patients
with LN is currently enrolling.
About PRESIDIO
PRESIDIO (NCT04033926) is a Phase 2 randomized, double-blind,
placebo-controlled, crossover, multicenter study to evaluate the
safety, tolerability, efficacy, PK and PD of treatment with KZR-616
in patients with active polymyositis or dermatomyositis. During the
32-week treatment period, patients will receive either KZR-616 or
placebo subcutaneously once weekly for 16 weeks followed by a
crossover to the other treatment arm for an additional 16 weeks.
The study is expected to enroll 24 patients. An open-label
extension study of PRESIDIO is now also enrolling.
About KZR-616
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 1a and 1b trials provide evidence that KZR-616 exhibits a
favorable safety and tolerability profile for development in
severe, chronic autoimmune diseases. Phase 2 trials are underway in
severe autoimmune diseases.
About Kezar Life Sciences
Based in South San Francisco, Kezar Life Sciences is combining
courage, conviction and cutting-edge science to develop
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 and
inhibit multiple drivers of disease via a single target. KZR-616, a
first-in-class selective immunoproteasome inhibitor, is being
evaluated in severe and underserved autoimmune diseases.
Additionally, KZR-261, the first clinical candidate for the
treatment of cancer from the company’s protein secretion program
targeting the Sec61 translocon, is undergoing IND-enabling
activities. For more information, visit www.kezarlifesciences.com,
and follow us on Twitter at @KezarBio, Facebook and LinkedIn.
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”
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 likelihood that data will support future
development, the association of data with treatment outcomes, the
design, progress, timing, scope and results of clinical trials, the
anticipated timing of disclosure of results of clinical trials and
the likelihood of obtaining regulatory approval of Kezar’s product
candidates. Many factors may cause differences between current
expectations and actual results, including the impacts of the
COVID-19 pandemic on the company’s business, clinical trials and
financial position, unexpected safety or efficacy data observed
during preclinical or clinical studies, clinical trial site
activation or enrollment rates that are lower than expected,
changes in expected or existing competition, changes in the
regulatory environment, 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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Media and Investor Contact:
Celia Economides SVP, Strategy & External Affairs
IR@kezarbio.com
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