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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.