Tobevibart

SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the enrollment of the first participant in the ECLIPSE 2 Phase 3 clinical trial, which is designed to compare the combination of tobevibart and elebsiran to continued bulevirtide monotherapy in participants with chronic hepatitis delta (CHD) who have not achieved undetectable hepatitis delta virus (HDV) RNA despite bulevirtide treatment. ECLIPSE 2 is one of three trials in Vir Biotechnology’s registrational ECLIPSE program for CHD, which was initiated in March 2025. ECLIPSE 2 is designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, including agencies in the U.S. and Europe. “Patients living with chronic hepatitis delta, a known cause of liver cancer, are waiting for effective options to change the course of their disease." “Patients living with chronic hepatitis delta, a known cause of liver cancer, are waiting for effective options to change the course of their disease,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “We are excited about the rapid progress of our ECLIPSE program, which demonstrates our unwavering commitment to deliver a highly effective treatment for people living with chronic hepatitis delta.” “We are encouraged by the transformational potential of tobevibart and elebsiran to rapidly drive the hepatitis delta virus to undetectable levels, as demonstrated by compelling data from our Phase 2 SOLSTICE clinical trial. We remain focused on advancing this investigational combination for chronic hepatitis delta with utmost urgency,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. CHD is the most severe form of chronic viral hepatitis,1 with people living with the disease rapidly progressing to cirrhosis, liver failure2 and liver-related death.1 There are currently no approved treatments 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. 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 Therapy and Fast Track designations, and by the European Medicines Agency (EMA) with Priority Medicines (PRIME) and orphan drug designations. About the ECLIPSE Registrational Program ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338), a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited, is currently recruiting. 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 2 plans to enroll participants in regions where bulevirtide is approved for the treatment of CHD. Participants who fail to achieve virologic suppression (defined as failure to achieve HDV RNA TND) after a minimum 24 weeks of bulevirtide treatment will be randomized 2:1 to switch to the combination of tobevibart and elebsiran or continue receiving bulevirtide. The primary endpoint in ECLIPSE 2 measures HDV RNA at the lower limit of quantification target not detected, HDV RNA TND (defined as HDV RNA = 0 IU/mL), at Week 24. 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. 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 indicate 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. 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 programs for chronic hepatitis delta 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 WHO Hepatitis Delta Factsheet – Hepatitis D (who.int), accessed June 2025 2 CDC What is Hepatitis D - FAQ | CDC, accessed June 2025 Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the combination of tobevibart and elebsiran to treat CHD and Vir Biotechnology’s belief that it can be a highly effective and transformative treatment option for these patients; Vir Biotechnology’s clinical development plans and expectations for the ECLIPSE Phase 3 registrational program, including protocols for and enrollment into ongoing and planned clinical studies, target endpoints and data readouts; Vir Biotechnology’s strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

The chronic hepatitis B market size is predicted to surge owing to the increasing prevalence of the disease globally and rising awareness about early diagnosis and treatment. Advances in antiviral therapies and the development of novel treatment options are fueling market expansion. LAS VEGAS, June 17, 2025 /PRNewswire/ -- Hepatitis B is the most widespread serious liver infection globally, caused by the hepatitis B virus (HBV), which targets and damages the liver. Millions of individuals worldwide are affected by chronic hepatitis B. The virus spreads through contact with infected blood and bodily fluids, including transmission via unprotected sex, sharing of contaminated needles, use of illegal drugs, and exposure to unsterilized medical equipment. In most cases, hepatitis B resolves on its own within 1 to 2 months. However, if the infection persists beyond six months, it can become chronic, potentially leading to ongoing liver inflammation, cirrhosis (liver scarring), liver cancer, or liver failure. As of 2024, around 5 million people across the 7MM were living with chronic hepatitis B. Among these, 85% had compensated liver function, while the remaining 15% had progressed to decompensated liver disease. Currently, there is no definitive cure for hepatitis B. Antiviral medications and interferon injections can help manage the disease by reducing viral activity and easing symptoms, but they do not eliminate the virus entirely. If the infection persists beyond six months, it is classified as chronic, making patients eligible for drug therapy, particularly those with active liver disease. Learn more about the chronic hepatitis B virus market @ New Treatment for Chronic Hepatitis B The US FDA has approved seven medications for treatment: two injectable interferons and five oral antiviral drugs. These treatments must be taken daily and work by suppressing viral replication, thereby reducing liver inflammation and potential damage. VEMLIDY (tenofovir alafenamide), developed by Gilead Sciences, is an innovative, targeted prodrug of tenofovir formulated as an oral tablet. In March 2024, Gilead announced that the FDA had approved a supplemental New Drug Application (sNDA) for VEMLIDY 25 mg, allowing its once-daily use in pediatric patients aged 6 years and older and weighing at least 25 kg who have chronic hepatitis B (CHB) infection with compensated liver disease. Earlier, in November 2022, the FDA approved the same 25 mg dose for once-daily use in children aged 12 and above with CHB and compensated liver disease. The initial FDA approval came in November 2016 for adult patients with CHB and compensated liver function. In January 2017, Gilead announced that the European Commission (EC) had granted marketing authorization for VEMLIDY 25 mg to treat CHB in adults and adolescents aged 12 and older who weigh at least 35 kg. Additionally, in December 2016, Japan's Ministry of Health, Labour and Welfare (MHLW) approved VEMLIDY for the treatment of chronic hepatitis B in patients showing active viral replication and abnormal liver function. Find out more on FDA-approved chronic hepatitis B drugs @ Chronic Hepatitis B (CHB) Market The chronic hepatitis B treatment drug market is continuously evolving. Several pharma companies are evaluating their lead assets in different phases of development. Many potential therapies are being investigated to manage chronic hepatitis B. Some of the drugs in the pipeline include Imdusiran (AB-729) (Arbutus Biopharma), GSK3228836 (bepirovirsen) (GlaxoSmithKline), Tobevibart (VIR-3434) + elebsiran (VIR-2218) ± PEG-IFN-a (Vir Biotechnology), and others. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2025–2034), it is safe to assume that the future of this market is bright. Discover which therapies are expected to grab major chronic hepatitis B treatment drug market @ Chronic Hepatitis B Market Report Daplusiran (also known as tomligisiran, formerly JNJ-3989/GSK5637608) is an experimental siRNA-based therapy targeting hepatitis B virus (HBV). It is being studied in combination with bepirovirsen in a sequential regimen for adult patients with chronic hepatitis B who are non-cirrhotic and receiving nucleos(t)ide analogue (NA) therapy. In October 2023, GSK and Arrowhead Pharmaceuticals announced an agreement with Janssen Pharmaceuticals to acquire the exclusive global rights to further develop and commercialize JNJ-3989. Janssen had originally licensed the drug (then called ARO-HBV) from Arrowhead in 2018. Imdusiran is an RNA interference (RNAi) therapy designed to suppress all HBV viral proteins and antigens, including HBsAg, which is believed to be critical for restoring the immune system's ability to fight the virus. It uses Arbutus' proprietary GalNAc-conjugated delivery platform to specifically target liver cells (hepatocytes), allowing for subcutaneous administration. Arbutus plans to launch a Phase IIb clinical trial in the first half of 2025 to evaluate imdusiran in combination with interferon (IFN) and NA therapy. Discover more about drugs for chronic hepatitis B in development @ Chronic Hepatitis B Clinical Trials The anticipated launch of these emerging therapies for chronic hepatitis B are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the chronic hepatitis B market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for chronic hepatitis B is expected to grow at a significant CAGR by 2034. In 2024, the United States dominated the CHB market among the 7MM, capturing approximately 72% of the total market share. The market size of chronic hepatitis B is expected to grow due to several factors, including rising global prevalence of hepatitis B virus infection and increasing awareness about the disease. Advances in antiviral therapies and growing screening initiatives also boost market growth by enabling early diagnosis and improved disease management. DelveInsight's latest published market report, titled as Chronic Hepatitis B Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the chronic hepatitis B country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The chronic hepatitis B market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Chronic Hepatitis B Total Diagnosed Cases of Chronic Hepatitis B Chronic Hepatitis B Cases by Age Group Chronic Hepatitis B Cases by Gender Treated Cases of Chronic Hepatitis B Chronic Hepatitis B Cases by Impact on Liver The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM chronic hepatitis B market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this chronic hepatitis B market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the chronic hepatitis B market. Also, stay abreast of the mitigating factors to improve your market position in the chronic hepatitis B therapeutic space. Related Reports Chronic Hepatitis B Epidemiology Chronic Hepatitis B Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the CHB epidemiology trends. Chronic Hepatitis B Pipeline Chronic Hepatitis B Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHB companies, including Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech Limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, among others. Hepatitis A Market Hepatitis A Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hepatitis A companies, including Boryung Pharmaceutical, Cadila Healthcare, Indian Immunologicals, Biological E Limited, among others. Hepatitis C Market Hepatitis C Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hepatitis C companies, including AbbVie, Gilead Sciences, Atea Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED