Surrozen Initiates Assay in Phase 1 Clinical Trial of
- SZN-1326 is an Fzd5 Targeted Wnt Mimetic (SWAP) bispecific antibody
- Beginning of the first part of the three-part Phase 1/1b trial in healthy volunteers
SOUTH SAN FRANCISCO, Calif., May 18, 2022 (GLOBE NEWSWIRE) — Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a clinical-stage company pioneering targeted therapies that selectively activate Wnt tissue repair and regeneration pathway, today announced that the first subject has received a dose in its three-part Phase 1 clinical trial to evaluate SZN-1326 for the potential treatment of moderate to severe ulcerative colitis. The start of the trial is about a quarter earlier than 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 of this novel approach for the treatment of inflammatory bowel disease.
The phase 1, randomized, placebo-controlled, single-dose, multiple-escalating-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 by intravenous injection or infusion, or subcutaneous injection in healthy volunteers, progressing from 25 mg to 1500 mg. The second part will evaluate multiple escalating doses of SZN-1326 over a four-week period in healthy volunteers, with each subject assigned to one of three dose level cohorts increasing from 75 mg IV to 750 mg IV. The primary endpoint of parts 1 and 2 of the trial is safety and tolerability of SZN-1326 and secondary outcomes include pharmacokinetics as well as anti-drug antibody (ADA) prevalence.
“The dosing of the first participant in our clinical study of SZN-1326 marks an important milestone for Surrozen as we officially transition to a clinical-stage organization,” said Craig Parker, President and CEO of Surrozen. “Furthermore, the assay marks an important step in advancing research into Wnt signaling, which plays a critical role in the regulation of many biological processes. I am proud of our team’s progress in creating uniquely designed antibodies that selectively modulate the Wnt pathway and their robust and rapid execution in completing our preclinical package and launching our clinical development program months earlier than foreseen. We look forward to continuing to build an extensive discovery and clinical pipeline of Wnt antibodies to repair a wide range of tissues and organs damaged by severe disease.
Trudy Vanhove, MD, Ph.D., Chief Medical Officer of Surrozen, added, “This trial is an important step towards bringing a new approach to patients with ulcerative colitis, who still have a significant need for treatments. which have a rapid onset of action, achieve mucosal healing and are non-immunosuppressive. We believe that SZN-1326 holds great promise in this area based on strong results from preclinical studies, including repair of damaged intestinal epithelium, improvement 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 candidate in development engineered 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 without adverse effects. treatment-related adverse events observed during 13-week toxicological evaluations in rats and non-human primates (NHP). Surrozen is initially developing SZN-1326 for moderate to severe ulcerative colitis. The phase 1 clinical study is published in the Australian New Zealand Clinical Trial Registry. Click HERE for publication SZN-1326.
About Wnt Signaling
Wnt signaling plays a key role in controlling the development, homeostasis, and regeneration of many essential organs and tissues, including the liver, intestine, lungs, kidneys, retina, central nervous system, cochlea, bones and others. Modulation of Wnt signaling pathways has potential for the treatment of degenerative diseases and tissue damage. Surrozen’s proprietary platform and technologies have the potential to overcome the limitations of pursuing the Wnt pathway as a therapeutic strategy.
Surrozen is a biotechnology company that discovers and develops drug candidates to selectively modulate the Wnt pathway. Surrozen develops tissue-specific antibodies designed to engage the body’s existing biological repair mechanisms with potential application in several disease areas including inflammatory bowel disease, hepatitis, eye disease, hearing loss, pulmonary and respiratory and certain neurological disorders. For more information, visit surrozen.com.
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements are generally accompanied by words such as “will”, “will”, “plan”, “potential”, “expect”, “advance”, “suggest”, “could” or the negative of these words and similar expressions that predict or indicate future events or trends or 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 using these product candidates 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 Surrozen’s management and are not predictions of actual performance. These forward-looking statements are provided for informational purposes only and are not intended to be relied upon and should not be relied upon as a guarantee, assurance, prediction or definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from the assumptions. Many real events and circumstances are beyond Surrozen’s control. 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 clinical trials regarding 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 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 could be adversely affected by the conflict between Russia and Ukraine; and the factors discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 under the heading “Risk Factors” and other documents that Surrozen has filed or will file with the Securities and Exchange Commission. If one of these risks materializes, or if 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 is not currently aware of, or that Surrozen currently believes are not material, 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 regarding future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its ratings to change. However, while Surrozen may choose to update these forward-looking statements at some time in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be taken to represent Surrozen’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed on forward-looking statements.
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