Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a
company pioneering targeted therapeutics that selectively activate
the Wnt Pathway for tissue repair and regeneration, today announced
that enrollment for the SZN-043 Phase 1a clinical trial in patients
with chronic liver disease and healthy volunteers is complete. The
Company expects to release safety and pharmacodynamic data in Q1
2024. In addition, Surrozen anticipates initiating enrollment in
the Phase 1b portion of the study in patients with
alcohol-associated hepatitis soon with proof-of-concept data from
the study potentially available in the second half of 2024.
Following the completion of the Phase 1 single ascending dose
clinical trial for SZN-1326, the Company will discontinue
development of SZN-1326 in inflammatory bowel disease (IBD). The
decision was based on the challenges of identifying a safe and
potentially effective dose along with strategic considerations
including the significant clinical development expenses and market
competition in IBD. SZN-1326 has been evaluated in a Phase 1 single
ascending dose clinical trial in 37 healthy volunteers in doses
ranging from 0.01mg to 25mg. Several subjects at higher dose levels
experienced asymptomatic liver transaminase elevations, including
four subjects with grade 3 ALT and AST elevations. The Company
previously reported that 3 of these 4 subjects had grade 3 ALT and
AST elevations in 2022. No other clinically significant laboratory
abnormalities were observed, and the transaminase elevations
resolved spontaneously in all subjects. No serious adverse events
were observed during the study. While no safety signal was observed
at lower doses, lower dose levels would not be expected to activate
Wnt signaling and produce a pharmacologic effect in the
intestine.
"Although the decision to discontinue the SZN-1326 inflammatory
bowel disease development program is disappointing, we want to
thank the subjects, our collaborators and the medical professionals
who participated and helped advance our understanding of Wnt
mimetics,” said Craig Parker, President and Chief Executive Officer
of Surrozen. “One of the compelling aspects of Wnt biology and our
technologies is the potential to apply them across a range of
potential tissues and diseases. Importantly, SZN-043 represents a
different antibody technology and approach to modulating Wnt
signaling compared to SZN-1326. Given the potential challenges in
IBD and attractive opportunities in other areas, we are excited to
continue to progress SZN-043 for alcohol-associated hepatitis,
advance our pipeline of research stage programs and support our
collaboration with Boehringer Ingelheim to advance SZN-413 into
development."
About SZN-043 for Alcohol-Associated
Hepatitis SZN-043 is the first development candidate
using Surrozen’s SWEETS™ technology. Surrozen is developing SZN-043
for severe liver diseases, initially focusing on alcohol-associated
hepatitis. The Company expects to announce safety and
pharmacodynamic data from SZN-043 Phase 1a clinical trial in
patients with chronic liver disease and in healthy volunteers in Q1
2024. The company anticipates enrolling patients with
alcohol-associated hepatitis in a Phase 1b clinical trial in 2024
and expects that proof-of-concept data from this trial may be
available in the second half of 2024.
About SZN-413 for Retinal Diseases SZN-413
is a bi-specific antibody targeting Fzd4-mediated Wnt signaling
designed using Surrozen’s SWAP™ technology. It is currently being
developed for the treatment of retinal vascular-associated
diseases. Data generated by Surrozen with SZN-413 in preclinical
models of retinopathy demonstrated that SZN-413 could potently
stimulate Wnt signaling in the eye, induce normal retinal vessel
regrowth, suppress pathological vessel growth and reduce vascular
leakage. This novel approach could thus potentially allow for
regeneration of healthy eye tissue, not only halting retinopathy,
but possibly allowing for a full reversal of the patient’s
disease.
In the fourth quarter of 2022, Surrozen entered into a strategic
partnership with Boehringer Ingelheim for the research and
development of SZN-413 for the treatment of retinal diseases. Under
the terms of the agreement, Boehringer Ingelheim received an
exclusive, worldwide license to develop SZN-413 and other
Fzd4-specific Wnt-modulating molecules for all purposes, including
as a treatment for retinal diseases, in exchange for an upfront
payment to Surrozen of $12.5 million. Surrozen will also be
eligible to receive up to $587.0 million in success-based
development, regulatory, and commercial milestone payments, in
addition to mid-single digit to low-double digit royalties on
sales. After an initial period of joint research, Boehringer
Ingelheim will assume all development and commercial
responsibilities.
About Wnt Signaling Wnt signaling plays
key roles in the control of development, homeostasis, and
regeneration of many essential organs and tissues, including liver,
intestine, lung, kidney, retina, central nervous system, cochlea,
bone, and others. Modulation of Wnt signaling pathways has
potential for treatment of degenerative diseases and tissue
injuries. Surrozen’s platform and proprietary technologies have the
potential to overcome the limitations in pursuing the Wnt pathway
as a therapeutic strategy.
About Surrozen Surrozen is a clinical
stage biotechnology company discovering and developing drug
candidates to selectively modulate the Wnt pathway. Surrozen is
developing tissue-specific antibodies designed to engage the body’s
existing biological repair mechanisms with a current focus on
severe liver and eye diseases. For more information, please visit
www.surrozen.com.
Forward Looking StatementsThis press release
contains certain forward-looking statements within the meaning of
the federal securities laws. Forward-looking statements generally
are accompanied by words such as “will,” “plan,” “intend,”
“potential,” “expect,” “could,” or the negative of these words and
similar expressions that predict or indicate future events or
trends or that are not statements of historical matters. These
forward-looking statements include, but are not limited to,
statements regarding Surrozen’s discovery, research and development
activities, in particular its development plans for its product
candidates SZN-043, and SZN-413 (including anticipated clinical
development timelines and the availability of data, the potential
for such product candidates to be used to treat human disease), the
potential and timeline to nominate the lead development candidate
pursuant to its partnership with Boehringer Ingelheim and its
expectations with respect to its cash runway. These statements are
based on various assumptions, whether or not identified in this
press release, and on the current expectations of the management of
Surrozen and are not predictions of actual performance. These
forward-looking statements are provided for illustrative purposes
only and are not intended to serve as, and must not be relied on as
a guarantee, an assurance, a prediction, or a definitive statement
of fact or probability. Actual events and circumstances are
difficult or impossible to predict and will differ from
assumptions. Many actual events and circumstances are beyond the
control of Surrozen. These forward-looking statements are subject
to a number of risks and uncertainties, including the initiation,
cost, timing, progress and results of research and development
activities, preclinical or and clinical trials with respect to
SZN-043, SZN-413 and potential future drug candidates; the
Company’s ability to fund its preclinical and clinical trials and
development efforts, whether with existing funds or through
additional fundraising; Surrozen’s ability to identify, develop and
commercialize drug candidates; Surrozen’s ability to successfully
complete preclinical and clinical studies for SZN-043, SZN-413, or
other future product candidates; the effects that arise from
volatility in global economic, political, regulatory and market
conditions; and all other factors discussed in Surrozen’s Annual
Report on Form 10-K for the year ended December 31, 2022 and
Surrozen’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023 under the heading “Risk Factors,” and other
documents Surrozen has filed, or will file, with the Securities and
Exchange Commission. If any of these risks materialize or our
assumptions prove incorrect, actual results could differ materially
from the results implied by these forward-looking statements. There
may be additional risks that Surrozen presently does not know, or
that Surrozen currently believes are immaterial, that could also
cause actual results to differ from those contained in the
forward-looking statements. In addition, forward-looking statements
reflect Surrozen’s expectations, plans, or forecasts of future
events and views as of the date of this press release. Surrozen
anticipates that subsequent events and developments will cause its
assessments to change. However, while Surrozen may elect to update
these forward-looking statements at some point in the future,
Surrozen specifically disclaims any obligation to do so, except as
required by law. These forward-looking statements should not be
relied upon as representing Surrozen’s assessments of any date
after the date of this press release. Accordingly, undue reliance
should not be placed upon the forward-looking statements.
Investor and Media
Contact: Investorinfo@surrozen.com
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