New Hope in Treating Severe Alcohol-Associated Hepatitis: Surrozen's Phase 1b Clinical Trial
Key Takeaways
- Surrozen has initiated dosing in its Phase 1b trial for SZN-043 targeting severe alcohol-associated hepatitis.
- The trial will evaluate safety, pharmacokinetics, immunogenicity, and efficacy endpoints like MELD and Lille scores.
- Results expected in the first half of 2025 could lead to groundbreaking treatments for severe liver diseases.
Did You Know?
Introduction to the Clinical Trial
Surrozen, Inc., a leading biotechnology company, has started dosing the first patient in its Phase 1b clinical trial for SZN-043. This trial targets patients with severe alcohol-associated hepatitis, a critical health condition.
Overview of the Phase 1b Trial
The Phase 1b clinical trial is an open-label, multi-center study aiming to enroll about 30 patients. The primary goals are to evaluate safety, how the body processes the drug (pharmacokinetics), the immune response to the drug (immunogenicity), and effectiveness through several endpoints including MELD and Lille scores, as well as overall survival. These scores are indicators of liver function and predict patient outcomes.
Significance of SZN-043
SZN-043 is a groundbreaking drug developed using Surrozen’s proprietary SWEETS™ technology, intended for treating severe liver disorders. The drug has already proven safe and tolerable in earlier Phase 1a trials, showing promise in activating liver repair mechanisms.
Potential Impact
Severe alcohol-associated hepatitis is a life-threatening condition with a high mortality rate and no significant treatment advancements in over five decades. This trial seeks to address this urgent need, offering a potential new therapy capable of improving patient survival and liver function.
How Wnt Signaling Works
Wnt signaling is crucial for the body’s development, maintenance, and repair of tissues. By modulating this pathway, Surrozen believes it can promote tissue regeneration in vital organs including the liver, providing new treatments for degenerative diseases.
Other Surrozen Developments
In addition to SZN-043, Surrozen is advancing SZN-413 for retinal diseases. This drug employs SWAP™ technology and shows promise in reversing retinopathy by promoting healthy retinal vessel regrowth and reducing abnormal vessel formation.
Collaboration with Boehringer Ingelheim
In 2022, Surrozen partnered with Boehringer Ingelheim to further develop SZN-413. This collaboration includes a significant upfront payment and potential milestone payments, underscoring the high expectations for this technology in treating retinal diseases.
Future Outlook
Surrozen anticipates sharing early proof-of-concept data for the SZN-043 trial in the first half of 2025, which could pave the way for new, effective treatments for severe liver diseases.
Message from Surrozen's Leadership
Craig Parker, the CEO of Surrozen, expressed enthusiasm for this major milestone. The company is gaining momentum in pioneering new treatments that harness the body's natural regenerative capabilities.
Conclusion
The start of the Phase 1b trial for SZN-043 marks a significant step forward in treating severe alcohol-associated hepatitis. There is hope that this novel therapeutic approach will offer a lifeline to patients struggling with this severe condition.
References
- Surrozen Inc.https://www.surrozen.com/
- Mayo Clinic - Alcoholic Hepatitishttps://www.mayoclinic.org/diseases-conditions/alcoholic-hepatitis/symptoms-causes/syc-20352850
- National Institute on Alcohol Abuse and Alcoholismhttps://www.niaaa.nih.gov/alcohols-effects-health/alcohol-use-disorder/clinical-complications/alcohol-hepatitis