Vir Biotech enrolls first patient in hepatitis delta virus trial

SAN FRANCISCO - Vir Biotechnology, Inc. (NASDAQ:VIR), currently trading at $5.24 and identified as undervalued by InvestingPro models, announced Thursday the enrollment of the first participant in its ECLIPSE 2 Phase 3 clinical trial, evaluating a combination therapy for chronic hepatitis delta (CHD) patients who haven’t responded to bulevirtide treatment.

The trial will compare the combination of tobevibart and elebsiran against continued bulevirtide monotherapy in patients who have not achieved undetectable hepatitis delta virus (HDV) RNA levels despite bulevirtide treatment.

ECLIPSE 2 is part of Vir’s three-trial registrational program for CHD initiated in March 2025. The study is designed to provide efficacy and safety data for potential submissions to global regulatory agencies, including those in the U.S. and Europe.

CHD is considered the most severe form of chronic viral hepatitis, with patients rapidly progressing to cirrhosis, liver failure and liver-related death. Currently, no treatments are approved in the U.S., with limited options available in the European Union and globally.

The investigational combination has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration, along with Priority Medicines and orphan drug designations from the European Medicines Agency.

ECLIPSE 2 will enroll participants in regions where bulevirtide is approved. Patients who fail to achieve virologic suppression after at least 24 weeks of bulevirtide treatment will be randomized 2:1 to either switch to the combination therapy or continue bulevirtide. The primary endpoint measures HDV RNA at the lower limit of quantification target not detected at Week 24.

Tobevibart is an investigational monoclonal antibody targeting hepatitis B surface antigen, while elebsiran is an investigational small interfering RNA designed to degrade hepatitis B virus RNA transcripts. Both are administered subcutaneously.

According to the press release statement, the company believes this combination has the potential to rapidly drive the hepatitis delta virus to undetectable levels. With earnings scheduled for August 6th and an overall ’FAIR’ financial health rating from InvestingPro, investors can access comprehensive analysis and 10+ additional ProTips through the platform’s detailed research reports.

In other recent news, Vir Biotechnology reported its first-quarter 2025 financial results, which showed a slight miss in earnings per share forecasts and a significant shortfall in revenue projections. The company’s EPS was -$0.88, just below the forecast of -$0.87, while revenue was reported at $3.03 million, much lower than the expected $13.65 million. Additionally, H.C. Wainwright adjusted its price target for Vir Biotechnology shares, reducing it to $15 from $110 but maintained a Buy rating. This revision came after the Phase 2 MARCH study on chronic hepatitis B virus treatment failed to meet functional cure thresholds for advancing to a Phase 3 trial without a global partner.

Despite this setback, the analyst remains optimistic about Vir’s future, highlighting the company’s ongoing work in chronic hepatitis delta virus treatment as a primary value driver. The ECLIPSE 1 Phase 3 trial is currently enrolling participants, with ECLIPSE 2 expected to start soon. Moreover, Vir Biotechnology has dosed the first patient in its Phase 1 clinical trial evaluating VIR-5525 for solid tumors. This trial will assess the safety and preliminary anti-tumor activity of VIR-5525, both as a monotherapy and in combination with pembrolizumab, in patients with EGFR-expressing solid tumors.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.