Surrozen Begins Dosing in Phase 1b Trial of SZN-043 for Severe Alcohol-Associated Hepatitis

Surrozen, Inc. (Nasdaq: SRZN), a biotechnology company specializing in targeted therapeutics for tissue repair and regeneration, has announced the commencement of a Phase 1b clinical trial for its lead product, SZN-043. This trial targets patients with severe alcohol-associated hepatitis, marking a significant step in the development of treatments for this high-mortality disease.

The Phase 1b clinical trial is designed as an open-label, multi-center study and will include around 30 patients. The primary objectives are to assess the safety, pharmacokinetics, and immunogenicity of SZN-043, along with several efficacy endpoints such as changes in MELD and Lille scores, which are indicators of clinical improvement and survival rates. The trial aims to gather proof-of-concept data by the first half of 2025.

Craig Parker, Surrozen's President and CEO, expressed enthusiasm about the trial's initiation, highlighting the company's efforts to secure regulatory approvals and start patient dosing as scheduled. He noted that the positive momentum from the Phase 1a clinical data, which showed promising safety and early signs of Wnt signal activation affecting liver function, provides a strong foundation for the Phase 1b trials.

Dr. Edward Gane, a hepatologist and professor of medicine at the University of Auckland, emphasized the urgent need for new treatments for severe alcohol-associated hepatitis, noting the high mortality rate and lack of significant advancements in survival over the past five decades. Dr. Gane expressed optimism about the potential clinical benefits of SZN-043 for these patients.

SZN-043 is notable for being the first therapeutic candidate developed using Surrozen’s SWEETS™ technology. The company is initially focusing this treatment on severe liver diseases, particularly alcohol-associated hepatitis. The earlier Phase 1a trial included patients with chronic liver disease and healthy volunteers, demonstrating acceptable safety and tolerability, along with target engagement and activation of the Wnt signaling pathway.

Additionally, Surrozen is developing another promising therapeutic, SZN-413, a bi-specific antibody targeting Fzd4-mediated Wnt signaling. This drug is being developed using the company's SWAP™ technology for the treatment of retinal vascular-associated diseases. Preclinical models have shown that SZN-413 can effectively stimulate Wnt signaling in the eye, promoting healthy retinal vessel growth and reducing pathological vessel leakage, which could potentially reverse retinopathy and restore healthy eye tissue.

In late 2022, Surrozen entered a strategic partnership with Boehringer Ingelheim to further develop SZN-413 for retinal diseases. The agreement grants Boehringer Ingelheim an exclusive, global license to develop and market SZN-413 and other Fzd4-specific Wnt-modulating compounds. In exchange, Surrozen received $12.5 million upfront and is eligible for up to $587 million in milestone payments, along with royalties on sales.

Wnt signaling is crucial for the development, maintenance, and repair of various organs and tissues, including the liver, intestine, lung, kidney, retina, and central nervous system. By targeting these pathways, Surrozen’s technologies offer promising new approaches to treat degenerative diseases and tissue injuries.

Surrozen continues to advance its pipeline of drug candidates designed to selectively modulate the Wnt pathway, with a focus on severe liver and eye diseases. The company's innovative platform aims to harness the body's natural repair mechanisms, potentially transforming treatments for a range of serious conditions.