Surrozen Publishes Article in Cellular and Molecular Gastroenterology and Hepatology Demonstrating that SZN-1326, a Selective Wnt Mimetic, Stimulated Robust Colon Epithelial Regeneration and Ameliorated Colitis in an Acute Model of IBD

SOUTH SAN FRANCISCO, Calif., May 16, 2022 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively modulate the Wnt pathway for tissue repair and regeneration, announced today the publication of an article by Surrozen scientists in the journal Cellular and Molecular Gastroenterology and Hepatology. The results seen with one of Surrozen’s proprietary Wnt mimetic antibodies highlight the potential for this novel approach to treating inflammatory bowel disease. Multiple molecules were evaluated in an acute Dextran Sodium Sulfate (DSS) mouse colitis model, including SZN-1326, a Wnt mimetic with specificity to Frizzled 5 (Fzd5) and low-density lipoprotein receptor-related protein 6 (LRP6). SZN-1326 demonstrated the most rapid and robust repair of the injured colon epithelium without affecting normal epithelium and without causing hyperplasia.

Current management of moderate to severe ulcerative colitis (UC) leaves a significant unmet medical need for drugs that can directly repair and regenerate the intestinal epithelium and can quickly induce clinical and histological remission in patients. Histologic remission is now increasingly regarded as an important treatment objective for UC, as the absence of microscopic disease activity predicts a better clinical course (Magro, 2020*). There are currently no approved therapies that directly repair the epithelial barrier. Additionally, treatment options are limited once anti-inflammatory agents have failed.

In the intestine, Wnt signaling plays an important role in maintaining integrity of the epithelium as part of tissue homeostasis and during injury repair. Since Wnt signaling in the intestinal mucosa is critical for repairing the intestinal epithelium (cells that line the intestine), modulation of Wnt signaling has the potential to achieve epithelial regeneration, reduction in inflammation, improvement in disease control and histological remission and mucosal healing. Surrozen designed an antibody-based platform that generates potent Wnt mimetics, which specifically target select Fzd receptors and co-receptors. In this paper, the effects of multiple Wnt mimetics were evaluated to identify the desired regenerative effects on injured tissue and absence of hyperplasia in uninjured tissues.

“Today Surrozen scientists reported results from studies showing that SZN-1326, a multivalent bispecific antibody that binds to Fzd5 and LRP6, produced the most potent effect directly impacting epithelial cells, driving transient expansion of both stem and progenitor cells, and promoting epithelial cell differentiation. Furthermore, we observed restoration of the damaged epithelial structure and reduction in inflammation,” said Wen-Chen Yeh, M.D., Ph.D., Chief Scientific Officer at Surrozen.

“The results presented in this article led to the development and evaluation of our lead molecule, SZN-1326. SZN-1326 is initially being developed for ulcerative colitis and we look forward to initiating Phase 1 clinical trials in the third quarter of 2022,” said Trudy Vanhove, M.D., Ph.D., Chief Medical Officer at Surrozen.

“The results in this paper further demonstrate Surrozen’s ability to effectively generate selective Wnt mimetic antibodies that stimulate tissue repair and renewal, and in this case, in an acute disease model of inflammatory bowel disease,” said Yang Li, Ph.D., Senior Vice President of biology at Surrozen. “We are pleased with the growing body of evidence demonstrating the promise of our Wnt mimetics for potential treatment of disease and injury in therapeutic areas like inflammatory bowel disease.”

*Magro F, Dougherty G, Peyrin-Biroulet, L, et al. ECCO Position Paper: Harmonisation of the approach to Ulcerative Colitis Histopathology. J Crohns Colitis. 2020; Nov 7, 14 (11):1503-1511. Doi: 10.1093/ecco-jcc/jjaa110.

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 SZN-1326
SZN-1326 is the first development candidate designed using Surrozen’s SWAPTM 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 intestine, stimulate intestinal epithelial regeneration, reduce inflammation and reduce disease activity. Surrozen is developing SZN-1326 for moderate to severe inflammatory bowel disease.

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,” “promise,” “plan,” “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 SZN-1326, including anticipated clinical development timelines, and the potential for such product candidate 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 and Surrozen’s other drug candidates; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to advance SZN-1326 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, primarily under the heading “Risk Factors,” our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, 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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