Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a
clinical-stage company pioneering targeted therapeutics that
selectively activate the Wnt pathway for tissue repair and
regeneration, today announced that the first subject has been dosed
in its three-part Phase 1 clinical trial to evaluate SZN-1326 for
the potential treatment of moderate to severe ulcerative colitis.
The trial initiation is approximately one quarter earlier than
previously expected. Surrozen also recently announced the
publication of an article by Surrozen scientists in the journal
Cellular and Molecular Gastroenterology and Hepatology The results
highlight the potential for this novel approach to treating
inflammatory bowel disease.
The Phase 1, randomized, placebo-controlled, single- and
multiple-ascending-dose study will evaluate the safety,
pharmacokinetics, and activity of SZN-1326. The first part of the
trial will evaluate single doses of SZN-1326 via intravenous
injection or infusion, or subcutaneous injection in healthy
volunteers, progressing from 25 mg through 1500 mg. The second part
will evaluate multiple ascending doses of SZN-1326 for a period of
four weeks in healthy volunteers, with each subject assigned to one
of three dose level cohorts increasing from 75 mg IV up to 750 mg
IV. The primary endpoint of Parts 1 and 2 of the trial are safety
and tolerability of SZN-1326 and secondary outcomes include
pharmacokinetics as well as prevalence of Anti-Drug Antibodies
(ADA).
“The dosing of the first participant in our clinical study of
SZN-1326 marks a significant milestone for Surrozen as we
officially transition to a clinical-stage organization,” said Craig
Parker, President and Chief Executive Officer of Surrozen. “In
addition, the trial marks a milestone in the advancement of Wnt
signaling research, which plays an essential role in regulating
many biological processes. I am proud of our team’s advances in
creating uniquely engineered antibodies that selectively modulate
the Wnt pathway and their strong and timely execution in completing
our preclinical package and initiating our clinical development
program months earlier than planned. We look forward to continuing
to build a broad discovery and clinical pipeline of Wnt antibodies
to repair a broad range of tissues and organs damaged by serious
disease.”
Trudy Vanhove, M.D., Ph.D., Chief Medical Officer of Surrozen,
added: “This trial is a significant step toward bringing a new
approach to patients with ulcerative colitis, who still have a
significant need for treatments that have a rapid onset of action,
attain mucosal healing and are non-immunosuppressive. We believe
SZN-1326 holds significant promise in this field based on the
strong results in preclinical studies, including repair of damaged
intestinal epithelium, improvements in disease activity, and
anti-inflammatory effects in models of intestinal injury.”
SZN-1326 for Moderate to Severe Ulcerative
Colitis SZN-1326 is the first development candidate
designed using Surrozen’s SWAP™ technology and targets the
Wnt-signaling pathway in the intestinal epithelium. In preclinical
animal models of acute and chronic colitis, SZN-1326 has been shown
to activate Wnt signaling in the diseased intestine, stimulate
intestinal epithelial regeneration, reduce inflammation and reduce
disease activity with no treatment related adverse effects observed
in 13-week toxicology evaluations in rats and non-human primates
(NHPs). Surrozen is initially developing SZN-1326 for moderate to
severe ulcerative colitis. The Phase 1 clinical study is posted to
the Australian New Zealand Clinical Trial Registry. Click HERE for
the SZN-1326 posting.
About Wnt SignalingWnt 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 SurrozenSurrozen is a 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 potential application across multiple disease
areas, including inflammatory bowel disease, hepatitis, eye
diseases, hearing loss, lung and airway diseases, and certain
neurological disorders. For more information, please visit
surrozen.com.
Forward Looking Statements This 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,” “continue,” “plan,”
“potential,” “expect,” “advance,” “suggest,” “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-1326, SZN-043, and SZN-413,
including anticipated clinical development timelines, and the
potential for such product candidates to be used to treat human
disease. 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-1326, SZN-413, SZN-043, and
potential future drug candidates; Surrozen’s ability to identify,
develop and commercialize drug candidates; Surrozen’s ability to
advance SZN-1326, SZN-043, SZN-413, or other future product
candidates into, and successfully complete, preclinical studies and
clinical studies; the effects of the ongoing coronavirus (COVID-19)
pandemic or other infectious diseases and natural disasters on
Surrozen’s business; volatility in global economic, regulatory and
market conditions, which may be adversely affected by the conflict
between Russia and Ukraine; and those factors discussed in our
Annual Report on Form 10-K for the year ended December 31, 2021
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
subsequent to the date of this press release. Accordingly, undue
reliance should not be placed upon the forward-looking
statements.
Media Contacts:CanaleCommIan Stone, Managing
DirectorTel.: (619) 518-3518Email: ian.stone@canalecomm.com
Ingrid Mezo, Account DirectorTel.: (301) 473-2881Email:
ingrid.mezo@canalecomm.com
Investor Contact:Email:
Investorinfo@surrozen.com
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