Vir Biotechnology announced a positive opinion from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) regarding orphan drug designation for tobevibart and elebsiran. These medications are intended for the treatment of chronic hepatitis delta (CHD). This positive opinion stems from promising preliminary Phase 2 SOLSTICE trial data. Twenty-four-week data from this trial will be presented at the AASLD The Liver Meeting in San Diego on November 18, 2024, followed by an investor conference call on November 19, 2024.
CHD, caused by the hepatitis delta virus (HDV), is a severe, progressive liver disease. Considered the most aggressive form of chronic viral hepatitis, it often leads to cirrhosis and liver failure within five years of infection. Currently, no approved treatment exists in the United States, and global treatment options remain limited.
The COMP’s positive opinion highlights the potential of the tobevibart and elebsiran combination to address the significant unmet need in CHD care. Clinical data suggests this combination could improve outcomes for patients with this devastating disease. The European Commission will now review the COMP’s opinion and consider granting orphan drug designation. This designation is reserved for medicines targeting rare, life-threatening, or chronically debilitating conditions lacking satisfactory treatment options. It offers incentives such as specialized scientific advice, reduced fees, and ten years of market exclusivity upon approval.
The U.S. Food and Drug Administration (FDA) granted fast track designation to the tobevibart and elebsiran combination for CHD treatment in June 2024. This designation aims to expedite the development and review of drugs addressing serious conditions with unmet medical needs.
The Phase 2 SOLSTICE trial is a multi-center, open-label, randomized study evaluating the safety, tolerability, and efficacy of tobevibart, both alone and in combination with elebsiran, in CHD patients. Primary endpoints include the proportion of participants with undetectable HDV RNA, ALT normalization, and treatment-emergent adverse events up to specified time points. Secondary endpoints focus on the proportion of participants with undetectable HDV RNA at various time points. Further details are available on clinicaltrials.gov.
Tobevibart, an investigational monoclonal antibody, targets the hepatitis B surface antigen. It aims to block the entry of hepatitis B and delta viruses into liver cells and reduce circulating viral particles. Engineered for an extended half-life, tobevibart is administered subcutaneously and is currently in clinical development for chronic hepatitis B and delta.
Elebsiran, an investigational siRNA, targets hepatitis B virus RNA, aiming to reduce hepatitis B surface antigen production. It demonstrates potential antiviral activity against both hepatitis B and delta viruses. Administered subcutaneously, elebsiran is also in clinical development for chronic hepatitis B and delta. It marks the first asset from Vir Biotechnology’s collaboration with Alnylam Pharmaceuticals to enter clinical studies.
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.
