Thunbnail image
News   >  Hepatology   >  

New Hope in Treating Severe Alcohol-Associated Hepatitis: Surrozen's Phase 1b Clinical Trial

Published: 6/4/2024
      
Surrozen
Phase 1b clinical trial
SZN-043
severe alcohol-associated hepatitis
liver disease treatment
Wnt pathway
SWEETS technology
liver regeneration
MELD score
Lille score

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?

Did you know that severe alcohol-associated hepatitis has had no major treatment advancements in over 50 years?

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

  1. Surrozen Inc.
    https://www.surrozen.com/
  2. Mayo Clinic - Alcoholic Hepatitis
    https://www.mayoclinic.org/diseases-conditions/alcoholic-hepatitis/symptoms-causes/syc-20352850
  3. National Institute on Alcohol Abuse and Alcoholism
    https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-use-disorder/clinical-complications/alcohol-hepatitis