The U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application and granted Fast Track designation to the combination of tobevibart and elebsiran for chronic hepatitis delta treatment.
Tobevibart, a monoclonal antibody, and elebsiran, a small interfering ribonucleic acid, have shown promising Phase 2 preliminary results. They have demonstrated high rates of virologic response and ALT normalization in participants with chronic hepatitis delta.
The World Health Organization classifies hepatitis delta as the most severe chronic viral hepatitis, with a rapid progression toward liver cancer and death. Approximately 12 million people worldwide suffer from this infection.
Vir Biotechnology, the company developing tobevibart and elebsiran, emphasizes the urgent need for effective treatments and their commitment to making this groundbreaking therapy accessible as soon as possible.
The Fast Track designation accelerates the development and review process for drugs addressing serious conditions with unmet medical needs.
An upcoming Phase 3 ECLIPSE trial will evaluate the safety and efficacy of the tobevibart and elebsiran combination against the current standard of care.
The SOLSTICE Phase 2 trial, with complete 24-week data expected in the fourth quarter, continues to assess the combination’s effectiveness.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
