Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved GSK’s Hibsago (bepirovirsen), an antisense oligonucleotide (ASO), as a functional cure for chronic hepatitis B (CHB) virus infection. It is approved in adult patients who have received at least six months of prior nucleos(t)ide analogue therapy and… Read More
A gene editing technology has shown promising early results in treating patients with Hepatitis B. Participants in the ELIMINATE-B trial were dosed in PBGENE-HBV, developed by gene editing company Precision BioSciences, at multiple ascending dose levels. Results show PBGENE-HBV, which comprises an ARCUS-encoding mRNA encapsulated in a lipid nanoparticle… Read More
Aligos Therapeutics and Xiamen Amoytop Biotech have entered into an exclusive license agreement to develop and commercialise pevifoscorvir sodium in Greater China for chronic hepatitis B virus (HBV) infection. Under the terms of the agreement, Aligos will receive an upfront milestone of $25 million and is eligible… Read More
Biopharmaceutical company Bluejay Therapeutics’ hepatitis drug candidate has achieved a 100% virologic response at week 48 of clinical trials. Brelovitug, an investigational, fully human, high-affinity monoclonal antibody (mAb), targets hepatitis B virus surface antigen (anti-HBsAg) in chronic hepatitis D (CHD). The company announced brelovitug achieved 100%… Read More
News round-up for 31 March – 4 April by DDW Senior Digital Content Editor Diana Spencer. The headlines this week have demonstrated the importance of antibody therapies, particularly in treating cancer, but also as potential therapeutics for a range of other diseases including hepatitis D and Alzheimer’s. Read More
Bluejay Therapeutics’ AZURE-1 global pivotal clinical trial evaluating brelovitug (BJT-778) for the treatment of chronic hepatitis D (CHD) has dosed its first patient. Brelovitug is an investigational fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) on both the hepatitis D virus… Read More
Precision BioSciences has announced positive initial results from the first administration of PBGENE-HBV in cohort 1, the lowest dose level of the ELIMINATE-B trial. The ELIMINATE-B trial is designed to investigate PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level… Read More
DDW Editor Reece Armstrong speaks to Cassie Gorsuch, Vice President, Gene Therapy, at Precision BioSciences about limitations in treating hepatitis B (HBV) and the company’s recent clinical trial application (CTA) approval in Moldova for its lead candidate PBGENE-HBV. RA: What are the limitations of current standard-of-care treatments for HBV? … Read More
Precision BioSciences has announced it will commence a Phase I clinical trial for its in vivo gene editing programme PBGENE-HBV, following Clinical Trial Application (CTA) approval in Moldova. PBGENE-HBV is designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B… Read More
A new study from Korea University suggests that treatment with direct-acting antivirals (DAAs) improves liver disease-related clinical outcomes in patients with chronic hepatitis C virus (HCV) infection and reduces liver fibrosis-based disease burden. In recent years, DAAs that block replication of HCV have dramatically transformed the… Read More
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. The news highlights this week all centre around significant US Food and Drug Administration… Read More
Every week, DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates in the DDW Highlights podcast. It is now also available in a concise vodcast format. The news highlights this week… Read More
News round-up for 5-9 August by DDW Senior Digital Content Editor Diana Spencer. The news highlights this week all centre around significant US Food and Drug Administration (FDA) regulatory decisions, including new approvals for drugs for solid tumours, hepatitis B and glioma. The top stories:… Read More
The US Food and Drug Administration (FDA) has cleared GigaGen’s application to initiate a Phase I trial of its polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339. It is the first recombinant polyclonal therapeutic in development to treat and functionally cure chronic… Read More
HB-400, a novel arenaviral therapeutic vaccine developed by HOOKIPA Pharma and Gilead Sciences, has been shown to generate robust T cell responses specific to hepatitis B virus with high antibody levels in a preclinical setting. A Phase I clinical trial to evaluate the safety and tolerability… Read More
The Scottish Medicines Consortium (SMC) has become the first UK health authority to permit routine NHS use of Gilead Sciences’ Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. The drug has been accepted for the treatment of chronic HDV infection in adult… Read More
