Bluejay Therapeutics has enrolled the first subject in the randomised AZURE-2 global Phase III clinical trial to assess pan-genotypic, fully human immunoglobulin G1 (IgG1) monoclonal antibody brelovitug, in comparison to Hepcludex (bulevirtide) for chronic hepatitis D (CHD) treatment.
AZURE-2 is designed as a controlled trial to compare the effects of brelovitug single agent of a 300 mg subcutaneous injection administered weekly at home, by self, with Hepcludex in adult CHD patients.
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The trial’s primary goal is to measure the proportion of subjects achieving a composite response at the mark of week 48.
This response is defined by the absence of detectable hepatitis D virus RNA and the normalisation of alanine aminotransferase (ALT) levels. High ALT levels are an indicator of liver inflammation that can lead to cirrhosis and liver cancer.
The trial is a pivotal part of brelovitug’s worldwide registration process.
Also referred to as BJT-778, the investigational brelovitug is said to target the surface antigen (anti-HBsAg) on the hepatitis D, as well as B viruses.
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By GlobalDataIts design aims to neutralise and eliminate the viruses and aids in depleting subviral particles containing HBsAg, potentially offering a favourable safety profile and treatment for CHD.
Bluejay holds the worldwide rights to brelovitug.
Subject enrolment in the global pivotal AZURE-1 study assessing the safety and efficacy of this therapy against delayed treatment remains on track.
Bluejay Therapeutics chief medical officer Nancy Shulman said: “Chronic hepatitis D is the most severe form of viral hepatitis, yet it remains underserved, with limited or no approved treatment options in most countries.
“The primary endpoints of the AZURE-1 and AZURE-2 trials include a composite measure of viral response and ALT normalisation. Evidence from large cohort studies in hepatitis B has shown an association between delayed ALT normalisation and increased risk of liver disease progression and liver cancer.”
In January, the US Food and Drug Administration (FDA) granted breakthrough therapy designation for brelovitug for CHD treatment.
In 2023, Bluejay reported the completion of a Phase Ia study and enrolment of the initial Phase Ib cohorts for BJT-778 targeting hepatitis B surface antigen.
