Vir Biotechnology Launches Phase 3 ECLIPSE Program for Chronic Hepatitis Delta Treatment
Vir Biotechnology, Inc. has officially enrolled its first patient in the Phase 3 ECLIPSE registrational program, a significant step in evaluating the efficacy and safety of the combination therapy tobevibart and elebsiran for treating chronic hepatitis delta (CHD). This program is a crucial part of Vir’s ongoing efforts to address the unmet needs of patients suffering from this debilitating liver disease.
Overview of the ECLIPSE Program
The ECLIPSE registrational program consists of multiple trials aimed at providing the necessary data for submission to regulatory agencies. The two Phase 3 trials, ECLIPSE 1 and ECLIPSE 2, are designed to deliver registrational data, potentially leading to the approval of the combination therapy. Additionally, ECLIPSE 3 is a Phase 2b trial that will provide supportive data for securing access and reimbursement strategies in key European markets. These studies are expected to establish tobevibart and elebsiran as a potential breakthrough treatment for CHD.
Vir Biotechnology’s Commitment to Advancing Patient Care
The launch of the ECLIPSE program represents a pivotal milestone for Vir Biotechnology, marking the company’s commitment to rapidly advancing innovative treatments. Marianne De Backer, M.Sc., Ph.D., MBA, CEO of Vir Biotechnology, highlighted the significance of this achievement, noting that the company’s proven track record in developing treatments that harness the immune system could lead to transformative therapies for patients with hepatitis delta.
“Our ability to move impactful treatments from discovery to patient care demonstrates our dedication to improving the lives of individuals suffering from challenging diseases,” De Backer stated.
Vir Biotechnology Launches Phase 3 ECLIPSE Program for Chronic Hepatitis Delta Treatment
Potential of Tobevibart and Elebsiran in Treating Hepatitis Delta
CHD, caused by the hepatitis delta virus (HDV), is one of the most severe forms of chronic viral hepatitis. The disease leads to progressive liver damage, often resulting in cirrhosis and liver failure within five years. The existing treatment landscape for CHD is extremely limited, with no approved therapies in the U.S. and few options available in Europe and globally. Therefore, the need for effective treatment options is urgent.
Tobevibart and elebsiran, which have shown promise in earlier trials, aim to tackle the virus’s lifecycle through multiple mechanisms. According to Mark Eisner, M.D., M.P.H., Chief Medical Officer at Vir Biotechnology, the results from the Phase 2 SOLSTICE trial suggest that the combination of tobevibart and elebsiran can rapidly reduce HDV levels to undetectable amounts, offering patients the potential for significant clinical benefits.
“We are excited to evaluate the combination further in our Phase 3 trials,” said Eisner, emphasizing the promise of this innovative approach to fighting hepatitis delta.
The Unmet Medical Need in Chronic Hepatitis Delta
Chronic hepatitis delta presents a major global health challenge, affecting millions of people and contributing to significant liver-related morbidity and mortality. The condition’s progression to cirrhosis and liver failure makes it one of the most severe forms of viral hepatitis, yet effective treatment options remain scarce. Given the high unmet medical need, any potential treatment that can eliminate the hepatitis delta virus would be a game-changer for patients worldwide.
Chari A. Cohen, DrPH, M.P.H., President of the Hepatitis B Foundation, voiced the importance of new treatment options for hepatitis delta, stating, “Chronic hepatitis delta can be a devastating diagnosis, leaving patients in the U.S. with uncertain futures and no approved treatment options. The potential for tobevibart and elebsiran to offer new hope to this community is incredibly exciting.”
Regulatory Recognition for Breakthrough Potential
The potential of tobevibart and elebsiran to address the significant gaps in CHD treatment has been acknowledged by regulatory authorities. The U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations to the combination, accelerating the development process. Additionally, the European Medicines Agency (EMA) has awarded Priority Medicines (PRIME) status and orphan drug designation to the program, recognizing the unmet need and promising therapeutic potential of these treatments.
These regulatory designations highlight the potential impact of tobevibart and elebsiran on the global fight against hepatitis delta and underscore the urgency of bringing this novel treatment to market as soon as possible.
Looking Ahead: The Future of Hepatitis Delta Treatment
As the ECLIPSE program advances through its clinical trials, Vir Biotechnology remains committed to developing therapies that can transform the lives of patients suffering from hepatitis delta and other serious diseases. The enrollment of the first patient in the Phase 3 program is just the beginning of what could be a new era in the treatment of this challenging liver disease.
With ongoing support from the scientific and medical communities, as well as regulatory agencies, the ECLIPSE trials are poised to make a lasting impact on the treatment landscape for chronic hepatitis delta. If successful, tobevibart and elebsiran could provide a much-needed solution for patients and offer a new hope for the future of liver disease management.
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.
