Promising Preliminary Results from Our Broad Hepatitis Clinical Program

Carey Hwang, MD, PhD , Senior Vice President, Head of Clinical Research, Vir Biotechnology, Inc.

This week, Vir researchers presented findings from our ongoing hepatitis trials, including chronic hepatitis delta (CHD), the deadliest form of the disease at AASLD, The Liver Meeting, one of the preeminent liver meetings in the world. Phase 2 SOLSTICE data evaluating Vir’s investigational candidates, VIR-3434, an antibody, and VIR-2218, an siRNA, as a potential treatment for this devastating disease showed promising preliminary results in this area of high unmet patient need.

In our ongoing Phase 2 SOLSTICE clinical trial, after three subcutaneous doses of either VIR-3434 or VIR-2218 monotherapy, six participants rolled over into combination therapy with VIR-3434 and VIR-2218. Preliminary results presented in a late-breaking oral presentation showed that of the five participants receiving combination therapy who reached Week 12, 100% had hepatitis delta virus (HDV) RNA less than the lower limit of quantification* with 4 of 5 having undetectable HDV RNA.** To date, no clinically significant increases from baseline ALT have been observed with VIR-3434 monotherapy or VIR-2218+VIR-3434 combination therapy regardless of baseline hepatitis B surface antigen (HBsAg) or HDV RNA. ALT elevations were observed in two participants who received VIR-2218 monotherapy.

Decreasing viral load is the primary goal for any viral infection to prevent progression of disease.

Why it Matters: A deadly disease, a huge unmet need

CHD occurs as a co-infection in about 12 million people worldwide living with chronic hepatitis B (CHB). However, this is likely an underestimate since many people are not screened for CHD given the very limited treatment options. Currently, there are no approved treatments for chronic viral suppression of CHD available in the U.S. and vaccination against CHB is the only way to prevent the disease.

With the only approved treatment currently available in Europe, only 12% of patients achieved virologic suppression with undetectable HDV RNA after 48 weeks of therapy. The treatment also requires lifelong administration of a daily subcutaneous injection to maintain virologic control.

An effective treatment that could achieve chronic suppression of CHD could have a positive impact on the lives of millions living with this deadly disease worldwide.

Raising the bar on CHD treatment

Vir’s goal is to develop a safe, highly efficacious regimen that only needs to be administered once or twice a month. While these are early results with a small number of study participants, they are highly promising and suggest progress toward our goal. We look forward to additional results from the SOLSTICE trial and continued development of VIR-2218 and VIR-3434 in CHD patients.

*The lower limit of quantitation (LLOQ) of HDV RNA is <63 IU/mL and the limit of detection (LOD) is 14 IU/mL.

**Undetectable HDV RNA is defined as < limit of detection, 14 IU/mL or ≥ 2 log10 IU/mL decrease from baseline.