Colitis-Associated Neoplasms

SZN-043 preclinical data shows rapid, transient increases in hepatocyte proliferation and was well tolerated in non-clinical toxicology studies SZN-1326 preclinical data shows improved intestinal epithelial healing, restored epithelial barrier, and reduced colitis-associated collagen deposition and was well tolerated in non-clinical toxicology studies SOUTH SAN FRANCISCO, Calif., Oct. 10, 2022 (GLOBE NEWSWIRE) -- 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 the presentation of data supporting the continued development of its lead therapeutic programs at United European Gastroenterology Week (UEGW), being held Oct. 8-11 in Vienna. “These data reinforce the compelling mechanism-based rationale for our lead clinical programs, SZN-1326 for the treatment of moderate to severe ulcerative colitis and SZN-043 for severe liver diseases, initially focusing on severe alcoholic hepatitis,” said Craig Parker, CEO of Surrozen. “Wnt signaling promotes intestinal stem cell renewal which is essential for intestinal epithelial regeneration and plays a key role in hepatocyte regeneration after liver injury. Data presented at UEGW demonstrate that both molecules potently, rapidly and safely enhance Wnt signaling. Phase 1 clinical trials of our SZN-1326 and SZN-043 programs were initiated in May and June, respectively, and are ongoing.” SZN-043 Posters/Abstracts 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 presented data showing that hepatocytes started to proliferate within 2 days after starting SZN-043 treatments and that this proliferation ceased around Day 6 despite continued exposure to SZN-043 for up to 14 days. Surrozen believes that the transient, self-limited hepatocyte proliferation induced by SZN-043, is likely controlled by negative feedback loops responsible for regulation of cell proliferation and liver homeostasis. In a poster entitled, “SZN-043, an R-Spondin mimetic in development for the treatment of liver disease, demonstrates a strong safety pro nonclinical toxicology studies,” Surrozen presented preclinical data showing that SZN-043, in 4-week mouse and cynomolgus monkey Good Laboratory Practice (GLP)-compliant toxicology studies, was well-tolerated at doses up to 125 mg/kg intravenously, twice weekly. SZN-043-related changes were considered non-adverse, limited to clinical chemistry and changes in organ weight and demonstrated evidence of recovery in most cases. There were no macroscopic or microscopic SZN-043-related observations and the no-observed-adverse-effect level (NOAEL) was the highest dose of 125 mg/kg. SZN-1326 Posters/Abstracts In an oral presentation entitled, “SZN-1326, a Wnt mimetic, improved epithelial healing and decreased collagen deposition in a dextran sulfate sodium-induced colitis mouse model,” Surrozen presented data showing that in an acute colitis mouse model, SZN-1326 treatment, in a dose-dependent manner, induced mucosal healing and restored the epithelial barrier resulting in reduced inflammation, reduced colitis‐associated collagen deposition, improved body weight and reduced disease activity. In a poster entitled, “SZN-1326, a tetravalent, bispecific antibody developed for the treatment of ulcerative colitis, has a favorable pro 13-week GLP toxicity studies,” Surrozen presented data showing that SZN-1326 has a favorable safety pro 13-week rat and cynomolgus monkey GLP-compliant toxicology studies, with no SZN-1326-related adverse events observed at the highest IV administered dose of 75 mg/kg weekly and 30 mg/kg weekly when dosed SC. The study found minimal, non-adverse, clinical pathology findings in rats, that were not correlated with any macro- or microscopic histopathological changes or clinical observations and the NOAEL was the highest IV administered dosage of 75 mg/kg/dose. 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 GLP compliant toxicology evaluations in rats and non-human primates (NHPs). Surrozen is initially developing SZN-1326 for moderate to severe ulcerative colitis. The first subject in the Phase 1 clinical study of SZN-1326 was dosed in May, and the trial is posted to the Australian New Zealand Clinical Trial Registry here. SZN-043 for Severe Alcoholic Hepatis SZN-043 is the first development candidate using Surrozen’s SWEETS™ technology which is designed to mimic the regenerative properties of the protein R-Spondin by enhancing Wnt signaling in a cell-targeted manner. 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 compliant toxicology evaluations in mice and NHPs. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on severe alcoholic hepatitis. The first subject in the Phase 1 clinical study of SZN-043 was dosed in June, and the trial 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, retina, lacrimal gland, lung, cornea, pancreas, skin 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 potential application across multiple diseases such as inflammatory bowel disease, hepatitis, eye diseases, and diseases of the lacrimal gland, lung and airway, pancreas, skin and many others. For more information, please visit surrozen.com 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,” “may,” “potential,” “believe,” “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-043, SZN-413, and potential future drug candidates; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to successfully complete preclinical and clinical studies for SZN-1326, SZN-043, SZN-413, or other future product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions, which may be adversely affected by the conflict between Russia and Ukraine and the ongoing coronavirus (COVID-19) pandemic; and all other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2021 under the heading “Risk Factors,” our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and other documents Surrozen has 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 Contact: Evoke Canale Ian Stone, Managing Director Tel.: (619) 849-5388 Email: ian.stone@evokegroup.com Investor Contact: Email: Investorinfo@surrozen.com