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Surrozen Initiates Dosing in Phase 1 Clinical Trial of SZN-043 for Severe Alcoholic Hepatitis
SZN-043 is a novel hepatocyte-specific R-spondin mimetic bispecific fusion protein targeting ASGR1First part of two-part Phase 1 trial starts in healthy
About this update from Surrozen, Inc.
[{"type":"text","content":"SZN-043 is a novel hepatocyte-specific R-spondin mimetic bispecific fusion protein targeting ASGR1First part of two-part Phase 1 trial starts in healthy volunteers SOUTH SAN FRANCISCO, Calif., June 13, 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 two-part Phase 1 clinical trial for SZN-043 which is in development for the potential treatment of severe alcoholic hepatitis. The Phase 1, randomized, single and multiple ascending dose study will evaluate the safety, pharmacokinetics and activity of SZN-043. The first part of the trial will evaluate single doses of SZN-043 administered via intravenous injection or infusion in healthy volunteers, progressing from 3 mg through 30 mg. The second part will evaluate multiple ascending doses of SZN-043 for a period of four weeks in patients with a documented history of liver cirrhosis and a Child-Pugh score between 5 and 7 at the 2 highest dose levels tolerated in part 1. The primary endpoint of the trial is safety and tolerability of SZN-043 and secondary outcomes include pharmacokinetics, pharmacodynamic markers as well as prevalence of Anti-Drug Antibodies (ADA). “We are gaining momentum as a clinical organization with two studies now enrolling subjects, and both reaching the clinic ahead of schedule,” said Craig Parker, President and Chief Executive Officer of Surrozen. “Our team has remained diligently focused on applying our Wnt research and platforms while rapidly advancing these uniquely engineered antibodies. We look forward to continuing to build on this momentum with SZN-043 and SZN-1326, as well as our research- and discovery-stage programs.” Trudy Vanhove, M.D., Ph.D., Chief Medical Officer of Surrozen, added: “Severe alcoholic hepatitis has a 30% mortality at 90 days and there remains a significant need for new acute treatment options for these patients. As a first step towards testing SZN-043 in severe AH patients, we are evaluating safety and pharmacokinetics of SZN-043 in healthy volunteers and patients with cirrhosis, a common feature in patients with severe AH. We will also be evaluating pharmacodynamic markers of Wnt activation, hepatocy...