Vir Biotechnology has enrolled the first subject in the Phase III ECLIPSE registrational programme of tobevibart and elebsiran in individuals with chronic hepatitis delta (CHD), an inflammatory liver condition.
The programme is designed to assess the safety and efficacy of the combination in this patient population.
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It includes the ECLIPSE 1 and ECLIPSE 2 Phase III trials, aiming to offer the registrational data required for regulatory submissions. The Phase IIb ECLIPSE 3 trial seeks to support access and reimbursement strategies in the European markets.
ECLIPSE 1 aims to enrol 120 subjects across the US and other select regions, comparing the combination therapy to deferred treatment.
Subjects will be randomised to receive either the combination or deferred treatment. Measuring HDV RNA and serum alanine aminotransferase normalisation at week 48 will be the trial’s primary endpoint.
ECLIPSE 2 focuses on subjects who have not obtained viral suppression with bulevirtide treatment, while ECLIPSE 3, the head-to-head trial, will evaluate the combination with bulevirtide in treatment-naïve individuals.
CHD is said to occur due to the hepatitis delta virus (HDV), leading to cirrhosis and liver failure within five years for many people affected.
Vir Biotechnology CEO Marianne De Backer said: “The start of the ECLIPSE programme 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.”
Tobevibart, a monoclonal antibody, and elebsiran, a small interfering ribonucleic acid, are the investigational candidates that were discovered by Vir Biotechnology and Alnylam Pharmaceuticals, respectively.
The combination therapy received breakthrough and fast track designation from the US Food and Drug Administration, as well as orphan drug and priority medicines status from the European Medicines Agency.
In September 2023, Vir dosed the first subject in the Phase I HVTN 142 trial of VIR-1388, a T-cell vaccine candidate aimed at preventing human immunodeficiency virus.
