Highlights 

  • Vir completes ECLIPSE 1 Phase 3 enrollment, marking a key milestone in its CHD program. 
  • Topline readout targeted for Q1 2027 following primary endpoint in late 2026. 
  • ECLIPSE 2 and 3 remain on track to advance regulatory and market access pathways. 
  • Combination therapy aims to expand treatment options for underserved CHD patients globally. 

Vir Biotechnology, Inc.NASDAQ:VIRhas completed participant enrollment in ECLIPSE 1, a Phase 3 clinical study evaluating the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta. 

ECLIPSE 1 is part of Vir’s broader ECLIPSE registrational program, which includes three late-stage trials designed to provide data for potential regulatory filings with agencies such as the U.S. Food and Drug Administration and the European Medicines Agency. 

The final participant in ECLIPSE 1 is projected to reach the trial’s primary endpoint in Q4 2026, with topline results expected in Q1 2027. Meanwhile, ECLIPSE 2 and ECLIPSE 3 continue enrolling participants in line with company timelines. 

Management Commentary 

Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer of Vir Biotechnology, commented: 

“Completing enrollment in our ECLIPSE 1 Phase 3 trial marks a major step toward submitting the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta to regulatory authorities worldwide. We remain committed to advancing our late-stage program with urgency to bring a much-needed therapeutic option to patients living with this serious disease.” 

Mark Eisner, MD, MPH, Chief Medical Officer of Vir Biotechnology, added: 

“The strong engagement in ECLIPSE 1 underscores both the unmet medical need in chronic hepatitis delta and the promise of our combination therapy. We are pleased with the progress across the entire ECLIPSE program and extend our gratitude to the investigators and patients participating in these pivotal trials.” 

About Chronic Hepatitis Delta 

Chronic hepatitis delta is the most aggressive form of chronic viral hepatitis and has been classified as carcinogenic by the International Agency for Research on Cancer. 

About the ECLIPSE Registrational Program 

The ECLIPSE program encompasses three randomized, controlled trials assessing the tobevibart + elebsiran combination in CHD patients: 

  • ECLIPSE 1 (NCT06903338): Compares combination therapy versus deferred treatment in regions with limited bulevirtide availability. 
  • ECLIPSE 2 (NCT07128550): Evaluates efficacy in patients with inadequate viral suppression on bulevirtide. 
  • ECLIPSE 3 (NCT07142811): A Phase 2b head-to-head study comparing the combination of therapy with bulevirtide in treatment-naïve individuals. 

ECLIPSE 1 and 2 are designed to provide data for regulatory submissions, while ECLIPSE 3 will generate supportive evidence for market access and reimbursement discussions.