Vir Biotechnology Announces Positive End-of-Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the MARCH Study at AASLD The Liver Meeting
Vir Biotechnology announced positive end-of-treatment results from Part B of the MARCH Phase 2 clinical study evaluating combinations of tobevibart and elebsiran for chronic hepatitis B treatment. The study showed promising HBsAg loss rates, with 39% of participants achieving HBsAg loss with the doublet regimen and 46% with the triplet regimen (including pegylated interferon alfa) in patients with low baseline HBsAg. No new safety concerns were identified, with treatment-emergent adverse events being generally mild to moderate. Key functional cure data from 24-week follow-up is expected in Q2 2025.
Vir Biotechnology ha annunciato risultati positivi al termine del trattamento dalla Parte B dello studio clinico di fase 2 MARCH, che valuta combinazioni di tobevibart ed elebsiran per il trattamento dell'epatite B cronica. Lo studio ha mostrato tassi promettenti di perdita di HBsAg, con il 39% dei partecipanti che ha raggiunto la perdita di HBsAg con il regime a doppio trattamento e 46% con il regime a triplo trattamento (incluso l'interferone alfa pegilato) in pazienti con basso HBsAg di base. Non sono emerse nuove preoccupazioni sulla sicurezza, con eventi avversi emergenti dal trattamento generalmente classificabili come lievi o moderati. I dati chiave sulla cura funzionale provenienti dal follow-up di 24 settimane sono attesi nel secondo trimestre del 2025.
Vir Biotechnology anunció resultados positivos al final del tratamiento de la Parte B del estudio clínico de fase 2 MARCH, que evalúa combinaciones de tobevibart y elebsiran para el tratamiento de la hepatitis B crónica. El estudio mostró tasas prometedoras de pérdida de HBsAg, con el 39% de los participantes logrando la pérdida de HBsAg con el régimen de doble terapia y 46% con el régimen de triple terapia (incluido el interferón alfa pegilado) en pacientes con HBsAg basal bajo. No se identificaron nuevas preocupaciones de seguridad, y los eventos adversos emergentes del tratamiento fueron generalmente leves a moderados. Se espera que los datos clave sobre la cura funcional del seguimiento de 24 semanas estén disponibles en el segundo trimestre de 2025.
Vir Biotechnology는 만성 B형 간염 치료를 위한 tobevibart와 elebsiran의 조합을 평가한 MARCH 2상 임상 연구의 B부분에서 긍정적인 치료 종료 결과를 발표했습니다. 연구 결과, 치료 시작 시 HBsAg 수치가 낮은 환자의 경우 39%의 참가자가 이중 요법으로 HBsAg 손실을 달성하였고, 46%는 삼중 요법(페길리화 인터페론 알파 포함)으로 HBsAg 손실을 달성했습니다. 새로운 안전성 우려는 발견되지 않았으며, 치료 중 발생하는 부작용은 일반적으로 경미하거나 보통이었습니다. 24주 추적 관찰에 대한 주요 기능적 치료 데이터는 2025년 2분기에 발표될 예정입니다.
Vir Biotechnology a annoncé des résultats positifs à la fin du traitement de la Partie B de l'étude clinique de phase 2 MARCH, qui évalue des combinaisons de tobevibart et d'elebsiran pour le traitement de l'hépatite B chronique. L'étude a montré des taux de perte de HBsAg prometteurs, avec 39% des participants atteignant une perte de HBsAg avec le régime à deux médicaments et 46% avec le régime à trois médicaments (y compris l'interféron alpha pegylé) chez les patients ayant un HBsAg de base faible. Aucune nouvelle préoccupation en matière de sécurité n'a été identifiée, les événements indésirables liés au traitement étant généralement légers à modérés. Des données clés sur la guérison fonctionnelle provenant du suivi de 24 semaines sont attendues au deuxième trimestre 2025.
Vir Biotechnology gab positive Ergebnisse am Ende der Behandlung aus Teil B der MARCH Phase 2-Studie bekannt, die Kombinationen aus tobevibart und elebsiran zur Behandlung der chronischen Hepatitis B bewertet. Die Studie zeigte vielversprechende HBsAg-Verlustquoten, mit 39% der Teilnehmer, die einen HBsAg-Verlust mit dem Doppelkombinationsregime erreichten und 46% mit dem Dreifachregime (einschließlich pegylierte Interferon alfa) bei Patienten mit niedrigem Ausgangs-HBsAg. Es wurden keine neuen Sicherheitsbedenken festgestellt, und behandlungsbedingte Nebenwirkungen waren im Allgemeinen mild bis moderat. Wichtige Daten zur funktionellen Heilung aus der 24-wöchigen Nachuntersuchung werden im 2. Quartal 2025 erwartet.
- 39% HBsAg loss rate achieved with doublet therapy in low baseline HBsAg patients
- 46% HBsAg loss rate achieved with triplet therapy in low baseline HBsAg patients
- 100% anti-HBs seroconversion in triplet regimen patients who achieved HBsAg loss
- Favorable safety profile with mild to moderate adverse events
- Lower overall response rates in patients with higher baseline HBsAg levels (16% doublet, 22% triplet)
- Final functional cure data not available until Q2 2025
- Current treatments remain life-long with disease progression risks
Insights
The end-of-treatment results from the MARCH Phase 2 study show promising efficacy for Vir's hepatitis B treatment combinations. The standout data points include
The anti-HBs seroconversion rates are particularly encouraging, with
While these results are promising, the key functional cure data expected in Q2 2025 will be critical for determining the treatment's long-term effectiveness and commercial viability. The global market opportunity is substantial, with 254 million people living with chronic hepatitis B.
This clinical milestone positions Vir Biotechnology favorably in the competitive hepatitis B treatment landscape. The company is targeting an unmet medical need, as current treatments require lifelong administration and don't prevent disease progression. A functional cure would represent a significant market opportunity.
The data's strength in low HBsAg patients provides a clear initial target population for commercialization. The flexibility of offering both doublet and triplet regimens could enhance market adoption. However, investors should note that the full commercial potential won't be clear until the functional cure data in 2025, which will be important for determining the treatment's market positioning and potential revenue impact.
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– No new safety concerns were identified, and treatment-emergent adverse events were generally mild to moderate –
– Late-breaking oral presentation of MARCH Part B study results at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® –
– Key functional cure data from 24-week follow-up expected in Q2 2025 –
Chronic hepatitis B (CHB) is a long-lasting, inflammatory liver disease caused by the hepatitis B virus (HBV)1. The World Health Organization estimates that 254 million people live with CHB, and an estimated 1.1 million yearly deaths are associated with the disease2. Complications from CHB may include liver cirrhosis, liver failure and liver cancer3. Although CHB can be treated, there is no cure1.
Participants in the trial received tobevibart and elebsiran alone (doublet regimen) or in combination with PEG-IFNα (triplet regimen). This analysis includes data from 51 participants in the doublet regimen arm and 27 participants in the triplet regimen arm at the end of treatment. Tobevibart was administered at 300 mg every 4 weeks; elebsiran, at 200 mg every 4 weeks; and PEG-IFNα at 180 µg weekly. Study primary endpoints include HBsAg seroclearance (defined as HBsAg below the lower limit of quantification) and treatment-emergent adverse events (TEAEs) at end of treatment. Secondary endpoints include anti-HBs seroconversion (defined as development of anti-HBs≥10 mIU/mL) at end of treatment.
The doublet and triplet regimens resulted in HBsAg loss at the end of treatment in
“People living with chronic hepatitis B must settle for life-long treatments that don’t eliminate the risk of disease progression to liver cancer,” said Edward J. Gane, M.D., Professor of Medicine at the University of
The safety and tolerability profile of tobevibart and elebsiran was consistent with prior studies, with no new safety concerns identified. TEAEs were generally mild or moderate.
“At Vir Biotechnology our ambition is to develop a functional cure for chronic hepatitis B following a finite treatment regimen. The MARCH data suggests that tobevibart and elebsiran can clear HBsAg and re-ignite the immune system, producing antibodies to potentially keep the virus under control,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. “We are encouraged by these results and eagerly anticipate the functional cure data in 2025, as it will be decisive for the next steps of clinical development.”
The data will be presented in the oral presentation Tobevibart (VIR-3434) and elebsiran (VIR-2218) with or without pegylated interferon alfa-2a for the treatment of chronic HBV infection: end of treatment results after 48 weeks of therapy (MARCH study) by Edward Gane, M.D., during a late breaking parallel session at AASLD The Liver Meeting® on November 18 at 5:00 pm PT.
Investor Conference Call
Vir Biotechnology will host an investor conference call on November 19, 2024 at 5:15 a.m. PT / 8:15 a.m. ET. A live webcast will be available on https://investors.vir.bio/ and will be archived on www.vir.bio for 30 days.
About the Phase 2 MARCH Trial
MARCH is a Phase 2 study to evaluate the safety, tolerability, and efficacy of regimens containing tobevibart (VIR-3434), elebsiran (VIR-2218), alone or in combination with pegylated interferon alfa in patients with chronic hepatitis B. This Phase 2 study is a multi-center, open-label, non-randomized study. Primary endpoints include HBsAg seroclearance (defined as HBsAg below lower limit of quantification) and treatment-emergent adverse events (TEAEs) at end of treatment, as well as HBsAg loss at 24 weeks post-end of treatment. Secondary endpoints include anti-HBs seroconversion (defined as development of anti-HBs≥10mIU/mL) at end of treatment. Participants who achieve HBsAg seroclearance at end of treatment will discontinue treatment, and functional cure (evaluated as sustained off-treatment HBsAg loss) assessment will occur 24 weeks after treatment discontinuation. More information about this trial can be found at clinicaltrials.gov (NCT04856085).
About Tobevibart
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’s proprietary monoclonal antibody discovery platform. Tobevibart is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta.
About Elebsiran
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 treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. It is the first asset in Vir’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. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to programs across several clinically validated targets in solid tumor indications. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies. Vir routinely posts information that may be important to investors on its website.
References:
1 CDC Hepatitis B Basics | Hepatitis B | CDC
2 WHO Hepatitis B Factsheet - Hepatitis B (who.int), accessed September 2024
3 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis B - NIDDK (nih.gov), accessed September 2024.
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’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’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’s multiple ongoing trials evaluating tobevibart and elebsiran, Vir’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’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’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’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
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