Surrozen Initiates Dosing in Phase 1 Clinical Trial of SZN-1326 for Moderate to Severe Ulcerative Colitis
- Category: Small Molecules
- Published on Wednesday, 18 May 2022 18:33
- Hits: 5911
- SZN-1326 is a Fzd5-targeted Wnt-mimetic (SWAP) bi-specific antibody
- First part of three-part Phase 1/1b trial starts in healthy volunteers
SOUTH SAN FRANCISCO, CA, USA I May 18, 2022 I 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 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.
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.