Tobevibart

SAN FRANCISCO, CA, USA I March 13, 2025 I Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the enrollment of the first patient in its Phase 3 ECLIPSE registrational program. The ECLIPSE registrational program is designed to evaluate the efficacy and safety of tobevibart in combination with elebsiran in people living with chronic hepatitis delta (CHD). ECLIPSE 1, the first trial of the program to be initiated, and ECLIPSE 2 are Phase 3 trials designed to provide the registrational data needed for submission to multiple regulatory agencies. ECLIPSE 3, a Phase 2b trial, is designed to provide important supportive data to help enable access and reimbursement strategies in key European markets. “The start of the ECLIPSE program marks a pivotal moment for patients living with hepatitis delta and for Vir Biotechnology. With a proven track record of developing treatments powering the immune system to transform lives this achievement is a testament to our ability to rapidly advance impactful treatments from discovery to patient care,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “The data from our SOLSTICE Phase 2 trial suggest that tobevibart and elebsiran can rapidly reduce hepatitis delta virus to undetectable levels, potentially driving important benefit for patients,” said Mark Eisner, M.D., M.P.H., Chief Medical Officer, Vir Biotechnology. “We are excited to further evaluate the potential of this combination in our Phase 3 program.” CHD is a debilitating inflammatory liver disease caused by the hepatitis delta virus (HDV). 1 It is the most severe form of chronic viral hepatitis 2 and on average, people living with CHD will progress to cirrhosis and liver failure within 5 years. 3 There is a high unmet medical need for effective treatments, as there are no approved therapies in the U.S., and options are limited in the European Union and globally. The objective of therapy is to eliminate the virus. Tobevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms. “Chronic hepatitis delta can be a devastating diagnosis, leaving all those impacted in the U.S. facing an uncertain future without approved treatment options,” said Chari A. Cohen, DrPH, M.P.H., President, Hepatitis B Foundation. “It is exciting to see potential new therapies for hepatitis delta, such as the combination of tobevibart and elebsiran, which could offer new hope to a community that has been waiting for efficacious treatment options for far too long.” The significant unmet need in CHD and the potential for tobevibart and elebsiran to provide a much-needed treatment option has been recognized by the U.S. Food and Drug Administration (FDA) with Breakthrough and Fast Track designations, and by the European Medicines Agency (EMA) Priority Medicines (PRIME) and orphan drug designation. About the ECLIPSE Registrational Program ECLIPSE is a Phase 3 registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta. ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1, the first trial of the program to be initiated, is a Phase 3 trial that will assess the efficacy and safety of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or other regions where its access is limited. ECLIPSE 2 is a Phase 3 trial that will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 is a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets. ECLIPSE 1 plans to enroll 120 participants in the U.S. or other regions where bulevirtide use is limited. Participants will be randomized 2:1 to receive either tobevibart in combination with elebsiran or deferred treatment. During the deferred treatment period, participants will receive only nucleoside reverse transcriptase inhibitors (NRTIs). After the initial delay period, participants will be switched to the combination therapy of tobevibart and elebsiran. The composite primary endpoint measures HDV RNA at the lower limit of quantification target not detected or HDV RNA TND (defined as HDV RNA < 0 IU/mL) and ALT normalization at Week 48, compared to the deferred treatment group at the end of their deferred treatment period. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B. About Vir Biotechnology, Inc. Vir Biotechnology, Inc., is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. References: 1 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D – NIDDK (nih.gov) , accessed February 2025 2 WHO Hepatitis Delta Factsheet – Hepatitis D (who.int) , accessed February 2025 3 CDC What is Hepatitis D – FAQ | CDC , accessed February 2025 SOURCE: Vir Biotechnology