Phase 2 Hepatitis Delta SOLSTICE Trial Enrollment Completed Early

Vir Biotechnology, a company dedicated to harnessing the immune system to combat various diseases, has made significant strides in its Phase 2 SOLSTICE clinical trial. This trial is focused on assessing the safety, tolerability, and effectiveness of two drugs, tobevibart and elebsiran, in treating chronic hepatitis delta (CHD) virus. The trial has recently completed enrollment for its current groups, a month ahead of schedule, with over 60 participants added in two new cohorts. One group is receiving tobevibart biweekly, and the other is receiving a combination of tobevibart and elebsiran monthly. The preliminary results are anticipated to be released in the second quarter of 2024.

Dr. Carey Hwang, Vir’s Senior Vice President of Clinical Research, highlighted the quick enrollment as an indicator of the strong interest from both patients and healthcare providers. This interest is driven by the urgent need for new treatment options for hepatitis delta patients, who are currently underserved. Vir is committed to developing a safe and effective chronic therapy to fill the existing treatment gap and is eagerly anticipating the release of more data later this year.

Among the participants in the trial, about half have compensated cirrhosis. In the upcoming second quarter, Vir plans to report additional 12-week treatment data for 30 participants and 24-week treatment data for 20 participants. The complete 24-week treatment data for all participants is expected by the end of 2024.

The SOLSTICE trial is a Phase 2, multi-center, open-label study that includes adult participants aged 18 to 69 with CHD infection who are also receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Depending on the group, participants are administered multiple doses of tobevibart and elebsiran, either alone or in combination, through subcutaneous injections for a period of up to 88 weeks. The primary goals of the trial are to measure the proportion of participants who achieve a significant reduction in HDV RNA levels compared to baseline or have undetectable HDV RNA levels, as well as the normalization of alanine transaminase (ALT) levels at Week 24.

Tobevibart is an experimental antibody administered via injection, designed to prevent the hepatitis B and delta viruses from entering liver cells and to reduce the amount of these viruses in the bloodstream. It has been engineered to potentially act as a T cell vaccine against both viruses and to have an extended half-life. Elebsiran, on the other hand, is an experimental siRNA that targets the hepatitis B virus and is believed to stimulate an immune response and have direct antiviral activity against both hepatitis B and delta viruses. It is the first siRNA in clinical trials to incorporate Enhanced Stabilization Chemistry Plus (ESC+) technology, which aims to enhance stability and minimize off-target effects.

Vir Biotechnology is an immunology-focused company that aims to transform lives by treating and preventing infectious diseases and other serious conditions. The company has developed two technology platforms designed to modulate the immune system based on observations of natural immune processes. Its pipeline includes product candidates for hepatitis delta and B viruses, as well as human immunodeficiency virus. Vir also has several preclinical candidates targeting influenza, COVID-19, RSV/MPV, and HPV.