Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta
Vir Biotechnology (VIR) has received FDA Breakthrough Therapy designation and EMA PRIME designation for its combination therapy of tobevibart and elebsiran in treating chronic hepatitis delta (CHD). These designations are based on positive safety and efficacy data from the Phase 2 SOLSTICE trial.
The company plans to initiate its Phase 3 ECLIPSE registrational program in the first half of 2025. CHD, the most severe form of chronic viral hepatitis, currently has no approved treatment in the U.S. and options globally. The Phase 2 trial data showed the combination therapy's ability to rapidly suppress the hepatitis delta virus to undetectable levels.
These new designations aim to expedite development and regulatory reviews, following earlier FDA Fast Track designation and EMA orphan drug designation.
Vir Biotechnology (VIR) ha ricevuto la designazione di Terapia Innovativa dalla FDA e la designazione PRIME dall'EMA per la sua terapia combinata di tobevibart ed elebsiran nel trattamento dell'epatite delta cronica (CHD). Queste designazioni si basano su dati positivi di sicurezza ed efficacia provenienti dalla fase 2 dello studio SOLSTICE.
L'azienda prevede di avviare il suo programma registrativo di fase 3 ECLIPSE nella prima metà del 2025. La CHD, la forma più grave di epatite virale cronica, non ha attualmente trattamenti approvati negli Stati Uniti né opzioni a livello globale. I dati della fase 2 hanno mostrato la capacità della terapia combinata di sopprimere rapidamente il virus dell'epatite delta a livelli non rilevabili.
Queste nuove designazioni mirano ad accelerare lo sviluppo e le revisioni normative, seguendo l'assegnazione precedente di Fast Track da parte della FDA e la designazione di farmaco orfano da parte dell'EMA.
Vir Biotechnology (VIR) ha recibido la designación de Terapia Innovadora por parte de la FDA y la designación PRIME de la EMA para su terapia combinada de tobevibart y elebsiran en el tratamiento de la hepatitis delta crónica (CHD). Estas designaciones se basan en datos positivos de seguridad y eficacia del ensayo SOLSTICE de fase 2.
La empresa planea iniciar su programa registracional de fase 3 ECLIPSE en la primera mitad de 2025. La CHD, la forma más severa de hepatitis viral crónica, actualmente no tiene tratamientos aprobados en los EE. UU. ni opciones a nivel global. Los datos del ensayo de fase 2 mostraron la capacidad de la terapia combinada para suprimir rápidamente el virus de la hepatitis delta a niveles indetectables.
Estas nuevas designaciones tienen como objetivo acelerar el desarrollo y las revisiones regulatorias, tras la anterior designación de Fast Track por parte de la FDA y la designación de medicamento huérfano de la EMA.
Vir Biotechnology (VIR)는 만성 델타 간염(CHD) 치료를 위한 tobevibart와 elebsiran의 병용 요법으로 FDA 혁신 치료제 지정과 EMA PRIME 지정을 받았습니다. 이들 지정은 임상 2상 SOLSTICE 시험에서의 긍정적인 안전성 및 유효성 데이터를 기반으로 하고 있습니다.
회사는 2025년 상반기에 3상 ECLIPSE 등록 프로그램을 시작할 계획입니다. CHD는 가장 심각한 형태의 만성 바이러스 간염으로, 현재 미국에서 승인된 치료법이 없으며 전 세계적으로도 선택지가 없습니다. 2상 시험 데이터는 병용 요법이 간염 델타 바이러스를 감지되지 않는 수준으로 신속하게 억제할 수 있다는 것을 보여주었습니다.
이러한 신규 지명은 FDA의 패스트 트랙 지정 및 EMA의 오르phan 약물 지정에 이어 개발 및 규제 검토를 신속하게 진행하기 위한 것입니다.
Vir Biotechnology (VIR) a reçu la désignation de Thérapie Innovante de la FDA et la désignation PRIME de l'EMA pour son traitement combiné de tobevibart et d'elebsiran dans le cadre du traitement de l'hépatite delta chronique (CHD). Ces désignations sont basées sur des données positives de sécurité et d'efficacité provenant de l'essai de phase 2 SOLSTICE.
L'entreprise prévoit de lancer son programme d'enregistrement de phase 3 ECLIPSE dans la première moitié de 2025. La CHD, la forme la plus sévère de l'hépatite virale chronique, n'a actuellement aucun traitement approuvé aux États-Unis et peu d'options à l'échelle mondiale. Les données de l'essai de phase 2 ont montré que la thérapie combinée est capable de supprimer rapidement le virus de l'hépatite delta à des niveaux indétectables.
Ces nouvelles désignations visent à accélérer le développement et les examens réglementaires, après la précédente désignation Fast Track de la FDA et la désignation de médicament orphan de l'EMA.
Vir Biotechnology (VIR) hat von der FDA die Auszeichnung als Durchbruchtherapie und von der EMA die PRIME-Auszeichnung für seine Kombinationstherapie mit tobevibart und elebsiran zur Behandlung der chronischen Deltahepatitis (CHD) erhalten. Diese Auszeichnungen basieren auf positiven Sicherheits- und Wirksamkeitsdaten aus der Phase-2-Studie SOLSTICE.
Das Unternehmen plant, sein registrierungspflichtiges Phase-3-Programm ECLIPSE in der ersten Hälfte des Jahres 2025 zu starten. CHD, die schwerste Form der chronischen Virushepatitis, hat derzeit keine genehmigten Behandlungen in den USA und weltweit. Die Daten der Phase-2-Studie zeigten, dass die Kombinationstherapie in der Lage ist, das Hepatitis-Delta-Virus schnell auf nicht nachweisbare Werte zu senken.
Diese neuen Auszeichnungen zielen darauf ab, die Entwicklung und die regulatorischen Prüfungen zu beschleunigen, nachdem zuvor die Fast Track-Auszeichnung der FDA und die Orphan-Drug-Auszeichnung der EMA erteilt wurden.
- Received FDA Breakthrough Therapy and EMA PRIME designations, potentially accelerating approval process
- Positive safety and efficacy data from Phase 2 SOLSTICE trial
- Addressing an unmet medical need with no approved treatments in US
- Phase 3 ECLIPSE program timeline confirmed for H1 2025
- Phase 3 trials not starting until H1 2025, indicating longer timeline to potential commercialization
Insights
The FDA Breakthrough Therapy and EMA PRIME designations for tobevibart and elebsiran represent a significant milestone in CHD treatment development. The dual regulatory fast-track status, supported by compelling Phase 2 SOLSTICE trial data, substantially increases the likelihood of expedited approval pathways in both major markets. This is particularly noteworthy given the current lack of approved treatments in the US and options globally for CHD, a severe condition affecting liver health.
The combination therapy's ability to achieve undetectable viral levels addresses a critical unmet medical need in CHD treatment. With Phase 3 ECLIPSE trials scheduled for H1 2025, Vir Biotechnology is positioned to potentially capture a significant share of the untapped CHD market. The multiple regulatory designations (Breakthrough, PRIME, Fast Track and pending Orphan Drug) provide various development advantages, including reduced review timelines and enhanced regulatory support.
These regulatory designations significantly enhance Vir's market position and development timeline advantages. The breakthrough status could accelerate the path to commercialization, potentially reducing development costs and time to market. For a company with a
The combination of FDA and EMA support provides dual-market potential, expanding the commercial opportunity. Given CHD's severity and lack of effective treatments, successful development could translate to significant revenue potential. The regulatory backing also increases the likelihood of partnership opportunities or potential acquisition interest from larger pharmaceutical companies looking to expand their liver disease portfolios.
– Designations aim to expedite the development and review of promising therapies for serious conditions with unmet medical needs –
– Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025 –
CHD is a chronic, progressive liver disease caused by the hepatitis delta virus1 and is the most severe form of chronic viral hepatitis2. CHD increases the risk of liver cancer and accelerates progression to cirrhosis and liver failure, which often occurs within 5 years of infection3. There is no approved treatment in the
“Chronic hepatitis delta has devastating effects on liver and overall health, yet people living with this condition are still waiting for highly effective therapeutic options,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. “The Phase 2 SOLSTICE trial data suggests that tobevibart and elebsiran can rapidly and deeply suppress the hepatitis delta virus, driving it to undetectable levels. Receiving FDA Breakthrough Therapy and European PRIME designations recognizes this combination’s potential to transform the lives of people living with CHD. We look forward to advancing the Phase 3 ECLIPSE program as quickly as possible.”
FDA Breakthrough Therapy designation aims to expedite the development and regulatory reviews of investigational therapies for serious conditions that demonstrate promising preliminary clinical evidence and potential improvement over existing therapies. EMA PRIME designation is granted to investigational medicines that target conditions with unmet medical needs for which no treatment option exists, or where they can offer a major therapeutic advantage over existing treatments. It fosters early exchange with the EMA to facilitate robust data collection, high-quality marketing authorization applications and expedited evaluations so that medicines can reach patients earlier. These designations follow FDA Fast Track designation and EMA Committee for Orphan Medicinal Products (COMP) positive opinion on orphan drug designation received earlier this year.
About the Phase 2 SOLSTICE Trial
SOLSTICE is a Phase 2 study to evaluate the safety, tolerability, and efficacy of tobevibart, alone or in combination with elebsiran, in patients with chronic hepatitis delta. This Phase 2 study is a multi-center, open-label, randomized study. Primary endpoints include proportion of participants with undetectable hepatitis delta virus (HDV) RNA (defined as HDV RNA equal or greater than 2 log10 decrease from baseline or below limit of detection) up to week 24, alanine aminotransferase (ALT) normalization (defined as ALT below upper limit of normal) up to week 24, and treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) up to 118 weeks. Secondary endpoints include proportion of participants with undetectable HDV RNA and different timepoints and up to 192 weeks. More information about this trial can be found at clinicaltrials.gov (NCT05461170).
About Tobevibart and Elebsiran
Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. 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, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta.
Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) 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 B and patients with chronic hepatitis delta. It is the first asset in Vir Biotechnology’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies.
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 double-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 September 2024.
2 WHO Hepatitis Delta Factsheet - Hepatitis D (who.int), accessed September 2024.
3 CDC What is Hepatitis D - FAQ | CDC.
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 “may,” “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. These forward-looking statements are based on Vir Biotechnology’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir Biotechnology’s strategy and plans, the potential clinical effects of tobevibart and elebsiran, the potential benefits, safety and efficacy of tobevibart and elebsiran, the timing, nature and significance of data from Vir Biotechnology’s multiple ongoing trials evaluating tobevibart and elebsiran, Vir Biotechnology’s plans and expectations for its CHD and CHB programs, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors; changes in expected or existing competition; delays in or disruptions to Vir Biotechnology’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. 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 trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause 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
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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 regulatory designations did VIR receive for tobevibart and elebsiran in 2024?
When will VIR begin Phase 3 trials for its CHD treatment?
What were the results of VIR's Phase 2 SOLSTICE trial for CHD treatment?
What is the current treatment landscape for CHD in the United States?
What additional regulatory designations has VIR received for its CHD treatment?
