Surrozen Reports Positive Safety and Efficacy Outcomes for SZN-043 in Clinical Trials

Surrozen, a biotech firm specializing in Wnt pathway therapeutics for tissue repair, has reported positive preliminary results from its Phase 1a clinical trial of SZN-043, a drug designed to treat severe alcohol-associated hepatitis. The trial, concluded in February 2024, involved 48 participants, including those with cirrhosis, and showed that SZN-043 was safe and well-tolerated, with no serious adverse events. The drug also demonstrated its intended biological effect, as indicated by target engagement and improvements in liver function metrics.
The Phase 1a findings included dose-dependent pharmacodynamic activity, confirmed by the methacetin breath test, which measures Wnt pathway activation. The test results were supported by transient increases in alkaline phosphatase levels, suggesting that SZN-043 effectively binds to its target receptor, ASGR1. Furthermore, the drug's pharmacokinetic profile was as anticipated, aligning with the planned dosing strategy for the upcoming Phase 1b trial.
Surrozen is now initiating a Phase 1b trial to further evaluate SZN-043's efficacy in treating severe alcohol-associated hepatitis. The company anticipates presenting detailed safety, pharmacodynamic, and pharmacokinetic data at a medical conference in 2024 and expects to have proof-of-concept data from the Phase 1b trial by mid-2025.
In addition to SZN-043, Surrozen is developing SZN-413, a bispecific antibody targeting Wnt signaling for retinal diseases. Preclinical data for SZN-413 have shown promising results in stimulating Wnt signaling and promoting healthy retinal vessel regrowth, potentially offering a novel treatment for retinopathy.
Surrozen has entered into a strategic partnership with Boehringer Ingelheim for the development of SZN-413. Under the agreement, Boehringer Ingelheim has obtained an exclusive license to develop SZN-413 and related Wnt-modulating molecules, with Surrozen receiving an initial payment and being eligible for further milestone-based payments and royalties.
The Wnt signaling pathway is crucial for the development and regeneration of various organs and tissues, making it a significant target for treating degenerative diseases and tissue injuries. Surrozen's proprietary technologies aim to harness the Wnt pathway's therapeutic potential.
As a clinical-stage company, Surrozen is focused on discovering and developing drug candidates that modulate the Wnt pathway, with an emphasis on severe liver and eye diseases. 
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