Vir Biotechnology Enrolls First Patient in Phase 3 ECLIPSE Registrational Program for Chronic Hepatitis Delta
Vir Biotechnology (Nasdaq: VIR) has initiated its Phase 3 ECLIPSE registrational program, enrolling the first patient to evaluate the combination of tobevibart and elebsiran for chronic hepatitis delta (CHD) treatment.
The program consists of three trials: ECLIPSE 1 and 2 (Phase 3) for registrational data submission to regulatory agencies, and ECLIPSE 3 (Phase 2b) to support access and reimbursement strategies in European markets. The combination therapy has shown promising results in the SOLSTICE Phase 2 trial, demonstrating ability to reduce hepatitis delta virus to undetectable levels.
CHD, the most severe form of chronic viral hepatitis, typically progresses to cirrhosis and liver failure within 5 years. Currently, there are no approved treatments in the U.S. and options globally. The therapy has received multiple regulatory recognitions, including FDA Breakthrough and Fast Track designations, and EMA Priority Medicines and orphan drug designation.
Vir Biotechnology (Nasdaq: VIR) ha avviato il suo programma registrativo di Fase 3 ECLIPSE, arruolando il primo paziente per valutare la combinazione di tobevibart ed elebsiran per il trattamento dell'epatite delta cronica (CHD).
Il programma consiste in tre studi: ECLIPSE 1 e 2 (Fase 3) per la presentazione dei dati registrativi alle agenzie regolatorie, e ECLIPSE 3 (Fase 2b) per supportare le strategie di accesso e rimborso nei mercati europei. La terapia combinata ha mostrato risultati promettenti nello studio SOLSTICE di Fase 2, dimostrando la capacità di ridurre il virus dell'epatite delta a livelli non rilevabili.
La CHD, la forma più grave di epatite virale cronica, progredisce tipicamente verso cirrosi e insufficienza epatica entro 5 anni. Attualmente, non ci sono trattamenti approvati negli Stati Uniti e le opzioni a livello globale sono limitate. La terapia ha ricevuto molteplici riconoscimenti regolatori, tra cui le designazioni di FDA Breakthrough e Fast Track, e le designazioni di EMA Priority Medicines e farmaco orfano.
Vir Biotechnology (Nasdaq: VIR) ha iniciado su programa registracional de Fase 3 ECLIPSE, inscribiendo al primer paciente para evaluar la combinación de tobevibart y elebsiran para el tratamiento de la hepatitis delta crónica (CHD).
El programa consta de tres ensayos: ECLIPSE 1 y 2 (Fase 3) para la presentación de datos registracionales a las agencias reguladoras, y ECLIPSE 3 (Fase 2b) para apoyar estrategias de acceso y reembolso en los mercados europeos. La terapia combinada ha mostrado resultados prometedores en el ensayo SOLSTICE de Fase 2, demostrando la capacidad de reducir el virus de la hepatitis delta a niveles indetectables.
La CHD, la forma más severa de hepatitis viral crónica, típicamente progresa a cirrosis e insuficiencia hepática en un plazo de 5 años. Actualmente, no hay tratamientos aprobados en los EE.UU. y las opciones a nivel global son limitadas. La terapia ha recibido múltiples reconocimientos regulatorios, incluidas las designaciones de FDA Breakthrough y Fast Track, y las designaciones de EMA Priority Medicines y medicamento huérfano.
Vir Biotechnology (Nasdaq: VIR)는 만성 델타 간염 (CHD) 치료를 위한 tobevibart와 elebsiran의 조합을 평가하기 위해 첫 번째 환자를 등록하여 3상 ECLIPSE 등록 프로그램을 시작했습니다.
이 프로그램은 세 가지 시험으로 구성됩니다: ECLIPSE 1 및 2 (3상)는 규제 기관에 제출할 등록 데이터를 위한 것이고, ECLIPSE 3 (2b상)는 유럽 시장에서의 접근 및 환급 전략을 지원하기 위한 것입니다. 이 조합 요법은 SOLSTICE 2상 시험에서 유망한 결과를 보여주었으며, 델타 간염 바이러스를 검출할 수 없는 수준으로 줄이는 능력을 입증했습니다.
CHD는 만성 바이러스 간염의 가장 심각한 형태로, 일반적으로 5년 이내에 간경변 및 간부전으로 진행됩니다. 현재 미국에서 승인된 치료법이 없으며, 전 세계적으로 선택할 수 있는 옵션이 제한적입니다. 이 치료법은 FDA의 Breakthrough 및 Fast Track 지정, 그리고 EMA의 Priority Medicines 및 희귀약 지정 등 여러 규제 인정을 받았습니다.
Vir Biotechnology (Nasdaq: VIR) a lancé son programme d'enregistrement ECLIPSE de Phase 3, en inscrivant le premier patient pour évaluer la combinaison de tobevibart et elebsiran pour le traitement de l'hépatite delta chronique (CHD).
Le programme se compose de trois essais : ECLIPSE 1 et 2 (Phase 3) pour la soumission de données d'enregistrement aux agences de réglementation, et ECLIPSE 3 (Phase 2b) pour soutenir les stratégies d'accès et de remboursement sur les marchés européens. La thérapie combinée a montré des résultats prometteurs dans l'essai SOLSTICE de Phase 2, démontrant sa capacité à réduire le virus de l'hépatite delta à des niveaux non détectables.
La CHD, la forme la plus sévère de l'hépatite virale chronique, progresse généralement vers la cirrhose et l'insuffisance hépatique dans les 5 ans. Actuellement, il n'existe aucun traitement approuvé aux États-Unis et les options à l'échelle mondiale sont limitées. La thérapie a reçu de multiples reconnaissances réglementaires, y compris les désignations FDA Breakthrough et Fast Track, ainsi que les désignations EMA Priority Medicines et médicament orphelin.
Vir Biotechnology (Nasdaq: VIR) hat sein Phase 3 ECLIPSE-Registrierungsprogramm gestartet und den ersten Patienten eingeschrieben, um die Kombination von tobevibart und elebsiran zur Behandlung der chronischen Deltahepatitis (CHD) zu bewerten.
Das Programm besteht aus drei Studien: ECLIPSE 1 und 2 (Phase 3) zur Einreichung von Registrierungsdaten bei den Zulassungsbehörden und ECLIPSE 3 (Phase 2b) zur Unterstützung von Zugangs- und Erstattungsstrategien auf den europäischen Märkten. Die Kombinationstherapie hat vielversprechende Ergebnisse in der SOLSTICE-Phase-2-Studie gezeigt und bewiesen, dass sie in der Lage ist, das Hepatitis-Delta-Virus auf nicht nachweisbare Werte zu reduzieren.
CHD, die schwerste Form der chronischen Virushepatitis, schreitet typischerweise innerhalb von 5 Jahren zu Zirrhose und Leberversagen fort. Derzeit gibt es in den USA keine zugelassenen Behandlungen, und die Optionen sind weltweit begrenzt. Die Therapie hat mehrere regulatorische Anerkennungen erhalten, darunter die FDA Breakthrough- und Fast Track-Auszeichnungen sowie die EMA Priority Medicines- und Orphan Drug-Auszeichnungen.
- First patient enrolled in Phase 3 registrational program, advancing towards potential regulatory approval
- Previous Phase 2 SOLSTICE trial demonstrated promising efficacy in reducing virus to undetectable levels
- Multiple regulatory designations received (FDA Breakthrough, Fast Track, EMA PRIME) accelerating development pathway
- Addressing large unmet medical need with no approved treatments in US market
- Long development timeline ahead with Phase 3 program just beginning
- Faces competition in EU market where some treatment options already exist
Insights
Vir Biotechnology's enrollment of the first patient in the Phase 3 ECLIPSE registrational program marks a significant milestone in the company's clinical development strategy. This program evaluates the combination of tobevibart and elebsiran for chronic hepatitis delta (CHD), an indication with substantial unmet medical need given no FDA-approved treatments exist in the US and options globally.
The ECLIPSE program's structure is particularly strategic, comprising two Phase 3 trials (ECLIPSE 1 and 2) for registrational data and a Phase 2b trial (ECLIPSE 3) designed to support European reimbursement. Previous data from the Phase 2 SOLSTICE trial demonstrated the combination's ability to reduce hepatitis delta virus to undetectable levels—a important efficacy marker.
The regulatory endorsements already secured are noteworthy, including FDA Breakthrough and Fast Track designations plus EMA Priority Medicines and orphan drug designations. These designations typically accelerate development timelines and signal regulatory recognition of both the treatment's potential and the disease severity.
CHD represents a significant commercial opportunity as the most severe form of viral hepatitis, with rapid progression to cirrhosis and liver failure within approximately 5 years. The mechanism targeting multiple aspects of the viral lifecycle positions this combination advantageously compared to existing treatment approaches.
The initiation of the ECLIPSE registrational program positions Vir strategically in the CHD treatment landscape, which currently represents a critical gap in hepatology therapeutics. The program's comprehensive design—with trials specifically structured to address regulatory requirements and European market access considerations—demonstrates sophisticated commercial planning.
CHD's aggressive disease progression creates an urgency-driven market, where effective therapies could command premium pricing. The combination approach targets viral elimination—the gold standard treatment goal—rather than merely managing viral suppression, potentially establishing it as a first-line therapy if approved.
The multi-mechanism approach combining tobevibart and elebsiran tackles different aspects of the viral lifecycle, addressing a key limitation of monotherapies. This dual-targeting strategy has proven successful in other viral diseases like HIV and HCV, often becoming the standard of care approach.
Vir's rapid advancement from Phase 2 to registrational studies suggests internal confidence in the asset and potential acceleration of timeline to market. With the regulatory pathways already enhanced through special designations, the development timeline could be compressed compared to standard programs, potentially bringing forward the commercialization opportunity if data continues to be positive.
-
First patient enrolled in ECLIPSE 1 Phase 3 clinical trial evaluating combination of tobevibart and elebsiran for chronic suppressive treatment
-
ECLIPSE program designed to enable regulatory submissions and support reimbursement and access
- Rapid study start indicative of significant unmet need for chronic hepatitis delta treatment
“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 hepatitis2 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
“Chronic hepatitis delta can be a devastating diagnosis, leaving all those impacted in the
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
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
ECLIPSE 1 plans to enroll 120 participants in the
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
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 offer transformative benefits 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20250313098877/en/
Media
Arran Attridge
Senior Vice President, Corporate Communications
aattridge@vir.bio
Investors
Richard Lepke
Senior Director, Investor Relations
rlepke@vir.bio
Source: Vir Biotechnology, Inc.
FAQ
What is the purpose of VIR's ECLIPSE Phase 3 program for chronic hepatitis delta?
How many clinical trials are included in VIR's ECLIPSE program?
What regulatory designations has VIR received for its hepatitis delta therapy?
What were the results from VIR's SOLSTICE Phase 2 trial?
