Surrozen has dosed the first subject in its two-part Phase I clinical trial of SZN-043, which is being developed to potentially treat severe alcoholic hepatitis.
A new hepatocyte-specific R-spondin mimetic bispecific fusion protein, SZN-043 acts on ASGR1.
The randomised, single and multiple ascending dose trial will assess the safety, pharmacokinetics and activity of SZN-043.
The initial part of the study will analyse single doses of SZN-043 given as intravenous injections or infusions in healthy subjects, progressing from 3mg to 30mg.
Multiple ascending doses of SZN-043 will be evaluated in the trial’s second part for four weeks in patients with a history of liver cirrhosis and a Child-Pugh score of five to seven at the two highest dose levels tolerated in part 1.
Assessing the safety and tolerability of SZN-043 is the primary endpoint of the trial.
Pharmacokinetics, pharmacodynamic markers and occurrence of anti-drug antibodies (ADA) will be analysed as the trial’s secondary outcomes.
Surrozen president and CEO Craig Parker said: “We are gaining momentum as a clinical organisation with two studies now enrolling subjects, and both reaching the clinic ahead of schedule.
“We look forward to continuing to build on this momentum with SZN-043 and SZN-1326, as well as our research- and discovery-stage programmes.”
In various preclinical animal models of liver injury and fibrosis, SZN-043 was demonstrated to selectively stimulate Wnt signalling in the liver, trigger transient hepatocyte proliferation, boost liver function and lower fibrosis without any treatment-linked adverse effects reported in four-week GLP toxicology analyses in mice and NHPs.
