Surrozen Presents Data on Lead Therapeutic Candidates at Digestive Disease Week (DDW)

SOUTH SAN FRANCISCO, Calif., May 24, 2022 (GLOBE NEWSWIRE) — Surrozen, Inc. (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today announced the presentation of data supporting the continued development of its lead therapeutic programs at Digestive Disease Week (DDW) 2022 in San Diego.

“These data represent the important progress and significant advances made in the scientific understanding of our lead therapeutic candidates, SZN-1326 and SZN-043,” said Craig Parker, CEO of Surrozen. “With our first clinical study of SZN-1326 now underway, and our clinical study of SZN-043 expected to begin in the third quarter of 2022, we look forward to further identifying their therapeutic potential.”

In an oral presentation entitled, “SZN-1326 promotes colonic mucosal healing in an acute injury model of IBD by first accelerating epithelial regeneration and secondarily reducing inflammation,” Surrozen presented data elucidating the mechanism of action of its proprietary Wnt mimetic, SZN-1326, a FZD5 and LRP6-specific, full-length, effectorless, bi-specific tetravalent IgG1 molecule. The data demonstrate that in an acute dextran sodium sulfate (DSS) epithelial damage model, SZN-1326 promoted mucosal healing by transiently inducing epithelial progenitor cell expansion and accelerating epithelial repair. The data further show that SZN-1326 also reduced stromal and immune cytokine signaling and immune cell infiltration.

In a poster entitled, “Modulation of Wnt signaling via a Wnt mimetic improved epithelial healing without causing hyperplasia in a mouse colitis model,” Surrozen presented data from an acute DSS mouse model for ulcerative colitis (UC). UC is characterized by epithelial lesions, and there is a need for therapies that promote mucosal healing. Wnt signaling plays critical roles in regulating intestinal stem cell maintenance and differentiation, and modulation of Wnt signaling could allow for epithelial restoration and histological remission. In this study, Surrozen’s Wnt mimetic repaired the damaged epithelium without causing hyperproliferation of epithelial cells in the intestine and improved body weight loss, demonstrating its therapeutic potential in IBD.

In a poster entitled, “SZN-043 induced quick and robust hepatocyte proliferation in a 14-day daily dosing Edu-labeling study in SCID mice,” Surrozen evaluated the kinetics and the overall effects of daily dosing of SZN-043 on hepatocyte proliferation in mice. Wnt/β-catenin signaling plays a key role in hepatocyte regeneration in homeostasis and after liver injury, and SZN-043, a hepatocyte specific R-spondin-mimetic, amplifies the signal of Wnt ligands by stabilizing and increasing the amount of Wnt receptors on the hepatocyte cell surface. Results showed hepatocytes responded quickly to SZN-043 treatment and underwent a limited number of proliferation cycles, despite the continued exposure to SZN-043 and β-catenin signaling induction for up to 14 days.

SZN-1326 for Moderate to Severe Ulcerative Colitis and SZN-043 for Severe Alcoholic Hepatis
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 here.

SZN-043 is the first development candidate designed using Surrozen’s SWEETS™ technology. In multiple preclinical animal models of liver injury and fibrosis, SZN-043 has been shown to selectively activate Wnt signaling in the liver, stimulate transient hepatocyte proliferation, improve liver function and reduce fibrosis with no treatment-related adverse effects observed in 4-week GLP toxicology evaluations in mice and NHPs. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on severe alcoholic hepatitis. Surrozen expects to initiate a Phase 1 clinical trial of SZN-043 in the third quarter if 2022. The Phase 1 clinical study is posted to the Australian New Zealand Clinical Trial Registry here.

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 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.

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