eClinical Technology and Industy News

Surrozen Initiates Dosing in Phase 1 Clinical Trial of SZN-1326 for Moderate to Severe Ulcerative Colitis

  • 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

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., May 18, 2022 (GLOBE NEWSWIRE) — 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.”

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